Fluid infusion systems

ABSTRACT

Fluid infusion systems such as a wearable fluid infusion device devoid of a user interface includes a housing configured to accommodate a fluid reservoir. The housing has a largest and a smallest dimension. The wearable fluid infusion device includes a drive system configured to be serially coupled to the fluid reservoir such that a dimension of the drive system and the fluid reservoir is less than or equal to the largest dimension. The wearable fluid infusion device includes a planar battery. The planar battery has a plurality of faces comprising one or more faces having a largest area, and the planar battery is situated such that the one or more faces are parallel to the largest dimension and the smallest dimension. The wearable fluid infusion device includes a means for coupling the housing with an adhesive plate configured to couple the wearable fluid infusion device to a user.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.62/858,304, filed on Jun. 6, 2019. The disclosure of the abovereferenced application is incorporated herein by reference.

FIELD

Embodiments of the subject matter described herein relate generally tomedical devices, such as fluid infusion devices. More particularly,embodiments of the subject matter relate to devices for a fluidinfusion, such as a fluid infusion device that is configurable for useas a fluid injection device, is configurable to be worn on a user's bodyand/or is configurable to be carried by a user. Embodiments of thesubject matter also relate to devices for fluid infusion, such as aninfusion set having an integrated physiological characteristic monitorfor use with the fluid infusion device.

BACKGROUND

Certain diseases or conditions may be treated, according to modernmedical techniques, by delivering a medication or other substance to thebody of a user, either in a continuous manner or at particular times ortime intervals within an overall time period. For example, diabetes iscommonly treated by delivering defined amounts of insulin to the user atappropriate times. Some modes of providing insulin therapy to a userinclude delivery of insulin through manually operated syringes andinsulin pens. Some other modes employ programmable fluid infusiondevices (e.g., insulin pumps) to deliver controlled amounts of insulinto a user.

A fluid infusion device suitable for use as an insulin pump may berealized as an external device or an implantable device, which issurgically implanted into the body of a user. External fluid infusiondevices include devices designed for use in a generally stationarylocation (for example, in a hospital or clinic), and devices configuredfor ambulatory or portable use (to be carried by a user). A fluid flowpath may be established from a fluid reservoir of a fluid infusiondevice to the patient via, for example, a set connector of an infusionset, which is coupled to the fluid reservoir.

In certain instances, an external fluid infusion device may becumbersome for the user to carry during the user's daily activities. Incertain instances, an infusion device may include features that arecomplex for a particular user, or that a particular user may not desire.Certain fluid infusion devices, due to their complexity, may also havean increased cost. Moreover, in certain instances, it may be desirablefor an infusion device to receive feedback from a physiologicalcharacteristic monitor, such as a continuous glucose monitor. In theseinstances, the physiological characteristic monitor and the infusion setare often separately coupled to the user's anatomy at differentinsertion sites.

Accordingly, it is desirable to provide an external fluid infusiondevice that is more convenient for a user to carry. In addition, it isdesirable to provide a fluid infusion device that is easier to use andhas a reduced cost. Further, it is desirable to provide a fluid infusiondevice that includes an infusion set integrated with a physiologicalcharacteristic sensor (e.g., a glucose sensor) so as to reduce thenumber of insertion sites. Furthermore, other desirable features andcharacteristics will become apparent from the subsequent detaileddescription and the appended claims, taken in conjunction with theaccompanying drawings and the foregoing technical field and background.

BRIEF SUMMARY

The techniques of this disclosure generally relate to a fluid infusiondevice and infusion sets associated with a fluid infusion device, suchas an insulin infusion pump for the treatment of diabetes.

According to various embodiments, provided is a portable fluid infusiondevice. The portable fluid infusion device includes a housing configuredto accommodate a removable fluid reservoir. The housing has a largestdimension and a smallest dimension. The portable fluid infusion deviceincludes a drive system configured to be serially coupled to theremovable fluid reservoir such that a combined dimension of the drivesystem and the removable fluid reservoir is less than or equal to thelargest dimension. The portable fluid infusion device includes a planarbattery configured to supply power to the drive system. The planarbattery has a plurality of faces comprising one or more faces having alargest area, and the planar battery being situated such that the one ormore faces are parallel to the largest dimension and the smallestdimension.

Also provided is a portable fluid infusion device. The portable fluidinfusion device includes a housing configured to accommodate a removablefluid reservoir, and a drive system configured to dispense fluid fromthe removable fluid reservoir. The portable fluid infusion deviceincludes a battery configured to supply power to the drive system, and auser interface without a display. The user interface includes a buttonand a light emitting element.

Further provided according to various embodiments is a wearable fluidinfusion device devoid of a user interface. The wearable fluid infusiondevice includes a housing configured to accommodate a removable fluidreservoir. The housing has a largest dimension and a smallest dimension.The wearable fluid infusion device includes a drive system configured tobe serially coupled to the removable fluid reservoir such that acombined dimension of the drive system and the removable fluid reservoiris less than or equal to the largest dimension. The wearable fluidinfusion device includes a planar battery configured to supply power tothe drive system. The planar battery has a plurality of faces comprisingone or more faces having a largest area, and the planar battery issituated such that the one or more faces are parallel to the largestdimension and the smallest dimension. The wearable fluid infusion deviceincludes a means for coupling the housing with an adhesive plateconfigured to couple the wearable fluid infusion device to a user.

Also provided is a wearable fluid infusion device devoid of a userinterface. The wearable fluid infusion device includes a housingconfigured to accommodate a removable fluid reservoir via a firstopening in the housing and to accommodate a disposable battery via asecond opening in the housing. The wearable fluid infusion deviceincludes a drive system configured to dispense fluid the removable fluidreservoir. The wearable fluid infusion device includes a means forcoupling the housing with an adhesive plate configured to couple thewearable fluid infusion device to a user.

Further provided according to various embodiments is a fluid infusionsystem. The fluid infusion system includes a housing configured to beadhesively coupled to an anatomy of a user, and a tube configured toextend from the housing for insertion into the anatomy of the user. Thetube includes a plurality of conduits defined within the tube. Theplurality of conduits include a fluid delivery conduit configured tofacilitate a fluidic connection between a fluid source and the anatomyof the user, and one or more conduits configured to accommodate aplurality of electrodes for determining a physiological characteristicof the user.

Also provided is a fluid infusion system that includes a housingconfigured to be adhesively coupled to an anatomy of a user and one ormore fluid delivery tubes configured to extend from the housing forinsertion into the anatomy of the user, thereby facilitating a fluidicconnection between a fluid source and the anatomy of the user. The fluidinfusion system includes a plurality of electrodes configured todetermine a physiological characteristic of the user. The plurality ofelectrodes are printed on the one or more fluid delivery tubes.

A fluid infusion system is also provided according to the variousembodiments. The fluid infusion system includes a housing configured tobe adhesively coupled to an anatomy of a user and a fluid delivery tubeconfigured to extend from the housing for insertion into the anatomy ofthe user, thereby facilitating a fluidic connection between a fluidsource and the anatomy of the user. The fluid infusion system includes asubstrate comprising a plurality of electrodes configured to determine aphysiological characteristic of the user, the substrate being coupled tothe fluid delivery tube such that the plurality of electrodes ispositioned below one or more fluid outlets defined in the fluid deliverytube.

Further provided according to various embodiments is a fluid infusionsystem. The fluid infusion system includes a means for determining aphysiological characteristic of a user, and a housing configured to beadhesively coupled to an anatomy of the user. The housing includes acommunication device configured to wirelessly communicate thephysiological characteristic to a communication component of a fluidinfusion device. The fluid infusion system includes a means for defininga fluid flow path from the fluid infusion device into the anatomy of theuser, and the means for defining the fluid flow path is configured toextend from the housing for insertion into the anatomy of the user.

Also provided is fluid infusion system. The fluid infusion systemincludes a housing configured to be adhesively coupled to an anatomy ofa user, and a means for determining a physiological characteristic ofthe user. The fluid infusion system includes a means for defining afluid flow path from a fluid infusion device into the anatomy of theuser. The means for defining the fluid flow path being configured toextend from the housing for insertion into the anatomy of the user, anda connector configured to secure the means for defining the fluid flowpath to the fluid infusion device. The connector includes acommunication device configured to communicate the physiologicalcharacteristic to a communication component of the fluid infusiondevice.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter. The details of one or more aspects of the disclosure are setforth in the accompanying drawings and the description below. Otherfeatures, objects, and advantages of the techniques described in thisdisclosure will be apparent from the description and drawings, and fromthe claims.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the subject matter may be derived byreferring to the detailed description and claims when considered inconjunction with the following figures, wherein like reference numbersrefer to similar elements throughout the figures.

FIG. 1 is a perspective view of an exemplary fluid infusion deviceaccording to various teachings of the present disclosure;

FIG. 2 is a bottom view of the fluid infusion device of FIG. 1;

FIG. 3 is a cross-sectional view of the fluid infusion device of FIG. 1,taken along line 3-3 of FIG. 2, in which a fluid delivery systemassociated with the fluid infusion device is removed;

FIG. 4 is an exploded view of the fluid infusion device of FIG. 1;

FIG. 5 is a cross-sectional view of the fluid infusion device of FIG. 1,taken along line 3-3 of FIG. 2, in which a fluid delivery systemassociated with the fluid infusion device is coupled to the fluidinfusion device;

FIG. 6 is an exploded view of a housing component of a housing of thefluid infusion device of FIG. 1;

FIG. 7 is a top view of the housing component of FIG. 6;

FIG. 8 is a side view of the housing component of FIG. 6;

FIG. 9 is a detail view of the housing component of FIG. 8, taken atSection 9 of FIG. 8;

FIG. 10 is a detail view of the fluid infusion device of FIG. 1, takenat Section 10 of FIG. 3;

FIG. 11 is a perspective view of an implementation involving anexemplary fluid infusion device according to various teachings of thepresent disclosure;

FIG. 12 is an end view of the fluid infusion device of FIG. 11;

FIG. 13 is an exploded view of the fluid infusion device of FIG. 11;

FIG. 14 is a top view of the fluid infusion device of FIG. 11;

FIG. 15 is a cross-sectional view of the fluid infusion device of FIG.11, taken along line 15-15 of FIG. 14;

FIG. 16 is a detail cross-sectional view, taken at Section 16 of FIG.15;

FIG. 17A is a cross-sectional view of the fluid infusion device of FIG.11, taken along line 17A-17A of FIG. 14;

FIG. 17B is a cross-sectional view of the fluid infusion device of FIG.11, taken along line 17B-17B of FIG. 14;

FIG. 17C is a cross-sectional view of the fluid infusion device of FIG.11, taken along line 17C-17C of FIG. 14;

FIG. 18 is a schematic illustration of an exemplary charging coilcoupled to a printed circuit board associated with a fluid infusiondevice;

FIG. 19 is another schematic illustration of an exemplary charging coilcoupled to a printed circuit board associated with a fluid infusiondevice;

FIG. 20A is an environmental view of a charging mat for use with acharging coil to charge a power supply associated with a fluid infusiondevice;

FIG. 20B is an environmental view of a charging dongle for use with acharging coil to charge a power supply associated with a fluid infusiondevice;

FIG. 20C is an environmental view of a charging cable that is used tocharge a power supply associated with a fluid infusion device;

FIG. 21 is a schematic illustration of a communication networkassociated with a fluid infusion device;

FIG. 22A is a perspective view of an infusion set assembly for use witha fluid infusion device, in which the infusion set assembly is uncoupledfrom the fluid infusion device;

FIG. 22B is a perspective view of an infusion set assembly for use witha fluid infusion device, in which the infusion set assembly is coupledto the fluid infusion device;

FIG. 22C is a detail view of a connector of an infusion set assemblycoupled to a housing of a fluid infusion device;

FIG. 22D is a cross-sectional view through the housing of the fluidinfusion device, which shows the connection between the connector andthe housing, and is taken along line 22D-22D of FIG. 22C;

FIG. 23A is a perspective view of an exemplary patch plate that isuncoupled from a fluid infusion device;

FIG. 23B is a perspective view of the patch plate and the fluid infusiondevice of FIG. 23A coupled together;

FIG. 24A is a perspective view of another exemplary patch plate that isuncoupled from a fluid infusion device;

FIG. 24B is a perspective view of the patch plate and the fluid infusiondevice of FIG. 24A coupled together;

FIG. 25 is a perspective view of an exemplary infusion set assembly foruse with a fluid infusion device, in which the infusion set assembly iscoupled to the fluid infusion device;

FIG. 26A is a perspective view of a needle connector that is uncoupledfrom a fluid infusion device;

FIG. 26B is a perspective view of the needle connector and the fluidinfusion device of FIG. 26A coupled together;

FIG. 27 is a perspective view of an exemplary fluid infusion systemaccording to various teachings of the present disclosure;

FIG. 28 is an exploded view of the fluid infusion system of FIG. 27;

FIG. 29 is a partially exploded view of the fluid infusion system ofFIG. 27, in which a first housing portion is separated from a secondhousing portion;

FIG. 30 is a perspective view of an implementation involving anexemplary fluid infusion device according to various teachings of thepresent disclosure;

FIG. 31 is an end view of the fluid infusion device of FIG. 30;

FIG. 32 is an exploded view of the fluid infusion device of FIG. 30;

FIG. 33 is a perspective view of an implementation involving a fluidinfusion device according to various teachings of the presentdisclosure;

FIG. 34 is an end view of the fluid infusion device of FIG. 33;

FIG. 35 is a perspective view of an implementation involving a fluidinfusion device according to various teachings of the presentdisclosure;

FIG. 36 is an end view of the fluid infusion device of FIG. 35;

FIG. 37A is a perspective view of an exemplary patch plate that isuncoupled from a fluid infusion device;

FIG. 37B is a perspective view of the patch plate and the fluid infusiondevice of FIG. 37A coupled together;

FIG. 38A is a perspective view of another exemplary patch plate that isuncoupled from a fluid infusion device;

FIG. 38B is a perspective view of the patch plate and the fluid infusiondevice of FIG. 38A coupled together;

FIG. 39 is a perspective view of an exemplary fluid infusion systemcomprising an infusion set assembly according to various teachings ofthe present disclosure;

FIG. 40 is a cross-sectional view of a tube of the infusion setassembly, taken along line 40-40 of FIG. 39;

FIG. 41 is a schematic side view of an infusion monitor unit of theinfusion set assembly of FIG. 39;

FIG. 42 is a perspective view of an exemplary implementation involving atube integrated with a physiological characteristic sensor;

FIG. 43 is a cross-sectional view of the implementation of FIG. 42,taken along line 43-43 of FIG. 42;

FIG. 44 is a cross-sectional view of the implementation of FIG. 42,taken along line 44-44 of FIG. 42;

FIG. 45 is a front perspective view of another exemplary implementationinvolving a tube integrated with a physiological characteristic sensor;

FIG. 46 is a cross-sectional view of the implementation of FIG. 45,taken along line 46-46 of FIG. 47;

FIG. 47 is a back perspective view of the implementation of FIG. 45;

FIG. 48 is a perspective view of another exemplary implementationinvolving a tube integrated with a physiological characteristic sensor;

FIGS. 49-52 depict an exemplary process for integrating a tube with aphysiological characteristic sensor;

FIG. 53 is a side view of an exemplary implementation involving a tubeand a physiological characteristic sensor;

FIG. 54 is a schematic view of the implementation of FIG. 53, in whichthe tube and the sensor are at least partially enveloped within aneedle;

FIG. 55 is a perspective view of the implementation of FIG. 53;

FIG. 56 is a front perspective view of another exemplary implementationinvolving a tube integrated with a physiological characteristic sensor;

FIG. 57 is a rear perspective view of the implementation of FIG. 56;

FIG. 58 is a perspective view of the implementation of FIG. 56, in whichthe tube and the sensor are at least partially enveloped within aneedle;

FIG. 59 is a perspective view of the implementation of FIG. 56, in whicha solid needle is extended through the tube;

FIG. 60 depicts an exemplary heat shrink tube for integrating a tubewith a physiological characteristic sensor;

FIG. 61 is a perspective view of an exemplary implementation involving atube, a physiological characteristic sensor, and a hollow needle;

FIG. 62 is an end view of the implementation of FIG. 61;

FIG. 63 is a top view of the implementation of FIG. 61;

FIG. 64 is a perspective view of another exemplary implementationinvolving a tube, a physiological characteristic sensor, and a hollowneedle;

FIG. 65 is an end view of the implementation of FIG. 64;

FIG. 66 is a top view of the implementation of FIG. 64;

FIG. 67 is a perspective view of another exemplary implementationinvolving a tube integrated with a physiological characteristic sensor;

FIG. 68 is an end view of the implementation of FIG. 67, in which thetube and the sensor are at least partially enveloped within a needle;

FIG. 69 is a top view of the implementation of FIG. 67, in which thetube and the sensor are at least partially enveloped within a needle;

FIG. 70 is a top view of an exemplary implementation involving a tubeand a physiological characteristic sensor that are at least partiallyenveloped within a needle;

FIG. 71 is an end view of the implementation of FIG. 70;

FIG. 72 is a top view of another exemplary implementation involving atube and a physiological characteristic sensor that are at leastpartially enveloped within a needle;

FIG. 73 is an end view of the implementation of FIG. 72;

FIG. 74 is a perspective view of the implementation of FIG. 72;

FIG. 75 is a top view of another exemplary implementation involving atube and a physiological characteristic sensor that are at leastpartially enveloped within a needle;

FIG. 76 is an end view of the implementation of FIG. 75 according tosome exemplary embodiments;

FIG. 77 is a top view of the implementation of FIG. 75;

FIG. 78 is an end view of another implementation involving a tube and aphysiological characteristic sensor that are at least partiallyenveloped within a needle according to some exemplary embodiments;

FIG. 79 is a top view of another exemplary implementation involving atube and a physiological characteristic sensor that are at leastpartially enveloped within a needle;

FIG. 80 is an end view of the implementation of FIG. 79;

FIG. 81 is a perspective view of the implementation of FIG. 79;

FIG. 82 is a top view of another exemplary implementation involving atube and a physiological characteristic sensor that are at leastpartially enveloped within a needle;

FIG. 83 is an end view of the implementation of FIG. 82;

FIG. 84 is a perspective view of the implementation of FIG. 82;

FIG. 85 is an end view of an exemplary implementation involving aplurality of tubules and a physiological characteristic sensor that areat least partially enveloped within a needle;

FIG. 86 is an end view of another exemplary implementation involving aplurality of tubules and a physiological characteristic sensor;

FIGS. 87-88 depict an exemplary process for forming a conduit using aribbon cable comprising a physiological characteristic sensor;

FIG. 89 is a schematic illustration of an infusion monitor unit coupledto an exemplary implementation involving a tube integrated with aphysiological characteristic sensor;

FIG. 90 is an end view of the implementation of FIG. 89;

FIG. 91 is an end view of another exemplary implementation involving atube integrated with a physiological characteristic sensor;

FIG. 92 is a perspective view of an exemplary implementation involving aphysiological characteristic sensor that is positioned within a tube;

FIG. 93 is a perspective view of another exemplary implementationinvolving a tube integrated with a physiological characteristic sensor;

FIG. 94 is a front perspective view of another exemplary implementationinvolving a tube integrated with a physiological characteristic sensor;

FIG. 95 is a rear perspective view of the implementation of FIG. 94;

FIG. 96 is a rear perspective view of another exemplary implementationinvolving a tube integrated with a physiological characteristic sensor;

FIG. 97 is a front perspective view of the implementation of FIG. 96;

FIG. 98 is a side view of the implementation of FIG. 96;

FIG. 99 is a schematic perspective view of a plurality of tubes whereineach tube is integrated with a physiological characteristic sensor;

FIG. 100 is another schematic perspective view of the plurality of tubesof FIG. 99;

FIG. 101 is a schematic perspective view of an exemplary implementationinvolving a plurality of tubes that is integrated with a physiologicalcharacteristic sensor;

FIG. 102 is a schematic end view of the implementation of FIG. 101 inwhich the plurality of tubes forms an enclosure;

FIG. 103A is a rear perspective view of another exemplary implementationinvolving a tube integrated with a physiological characteristic sensor;

FIG. 103B is a cross-sectional view of the implementation of FIG. 103A,taken along line 103B-103B of FIG. 103A;

FIG. 104A is a rear perspective view of another exemplary implementationinvolving a tube integrated with a physiological characteristic sensor;

FIG. 104B is a cross-sectional view of the implementation of FIG. 104A,taken along line 104B-104B of FIG. 104A;

FIG. 105 is a perspective view of another exemplary fluid infusiondevice having a device communication component for communicating with aninfusion set assembly that includes a communication component and aninfusion monitor unit for measuring a physiological characteristic of auser, such as a blood glucose level, and for delivering a fluid to theuser;

FIG. 106 is an end view of a connector in which a communicationcomponent has been removed for clarity;

FIG. 107 is a perspective view of the connector of the infusion setassembly coupled to a fluid reservoir of the fluid infusion device ofFIG. 105;

FIG. 108 is an exploded view of the connector and the communicationcomponent;

FIG. 109 is a perspective view of the communication component;

FIG. 110 is a detail view of the connector, in which the communicationcomponent is coupled to the connector;

FIG. 111 is a partially exploded view of the fluid infusion device ofFIG. 105, in which the connector is coupled to the fluid reservoirassociated with the fluid infusion device;

FIG. 112 is a perspective view of a connector having another exemplarycommunication component for communicating with another exemplary devicecommunication component associated with the fluid infusion device ofFIG. 105, in which the connector is coupled to the fluid reservoir ofthe fluid infusion device;

FIG. 113 is a perspective view of the connector and fluid infusiondevice of FIG. 112, in which the connector is uncoupled from the fluidinfusion device;

FIG. 114 is an exploded view of the connector and the communicationcomponent;

FIG. 115 is a perspective view of the communication component;

FIG. 116 is a detail view of the connector, in which the communicationcomponent is coupled to the connector;

FIG. 117 is a cross-sectional view of the fluid infusion device, takenalong line 117-117 of FIG. 113, which illustrates the devicecommunication component;

FIG. 118 is a detail view of the device communication component;

FIG. 119 is a perspective view of the connector coupled to the fluidinfusion device, in which a portion of a housing of the fluid infusiondevice is removed to illustrate the electrical and mechanical couplingbetween the communication component and the device communicationcomponent;

FIG. 120 is a detail view of the electrical and mechanical couplingbetween the communication component and the device communicationcomponent;

FIG. 121 is a detail view of another exemplary communication componentcoupled to a connector for communicating with the device communicationcomponent of the fluid infusion device of FIG. 112;

FIG. 122A is a side view of the connector of FIG. 121;

FIG. 122B is a detail side view of a portion of the connector of FIG.121 taken from FIG. 122A;

FIG. 123 is a perspective view of a connector having another exemplarycommunication component for communicating with another exemplary devicecommunication component associated with the fluid infusion device ofFIG. 105, in which the connector is coupled to the fluid reservoir ofthe fluid infusion device;

FIG. 124 is a partially exploded view of the connector and thecommunication component;

FIG. 125 is an exploded view of a portion of the communication componentand the connector;

FIG. 126 is a perspective view of the communication component;

FIG. 127A is a side view of the connector of FIG. 123;

FIG. 127B is a detail side view of a portion of the connector of FIG.123 taken from FIG. 127A;

FIG. 128 is an end view of the fluid infusion device, which illustratesthe device communication component;

FIG. 129 is a detail view of the device communication component;

FIG. 130 is a schematic side view of another exemplary infusion monitorunit for measuring a physiological characteristic of a user, such as ablood glucose level, and for delivering a fluid to the user, which isassociated with an infusion set assembly and is for use with a fluidinfusion device, such as the fluid infusion device of FIG. 11;

FIG. 131 is a cross-sectional view of a tube associated with theinfusion monitor unit of FIG. 130, taken along line 131-131 of FIG. 130;

FIG. 132 is an exemplary schematic circuit diagram for the infusionmonitor unit of FIG. 130;

FIG. 133 is a top view of the infusion monitor unit of FIG. 130, inwhich a portion of the housing has been removed;

FIG. 134 is a schematic side view of another exemplary infusion monitorunit for measuring a physiological characteristic of a user, such as ablood glucose level, and for delivering a fluid to the user, which isassociated with an infusion set assembly and is for use with a fluidinfusion device, such as the fluid infusion device of FIG. 11;

FIG. 135 is a top view of the infusion monitor unit of FIG. 134, inwhich a portion of the housing has been removed;

FIG. 136 is a schematic side view of another exemplary infusion monitorunit for measuring a physiological characteristic of a user, such as ablood glucose level, and for delivering a fluid to the user, which isassociated with an infusion set assembly and is for use with a fluidinfusion device, such as the fluid infusion device of FIG. 11 in a firststate;

FIG. 137 is a cross-sectional view of a tube associated with theinfusion monitor unit of FIG. 136, taken along line 137-137 of FIG. 138;

FIG. 138 is a schematic side view of the infusion monitor unit of FIG.136 in a second state;

FIG. 139 is a cross-sectional view of a glucose sensor associated withthe infusion monitor unit of FIG. 136, taken along line 139-139 of FIG.138;

FIG. 140 is a schematic side view of another exemplary infusion monitorunit for measuring a physiological characteristic of a user, such as ablood glucose level, and for delivering a fluid to the user, which isassociated with an infusion set assembly and is for use with a fluidinfusion device, such as the fluid infusion device of FIG. 11;

FIG. 141 is a schematic side view of another exemplary infusion monitorunit for measuring a physiological characteristic of a user, such as ablood glucose level, and for delivering a fluid to the user, which isassociated with an infusion set assembly and is for use with a fluidinfusion device, such as the fluid infusion device of FIG. 11;

FIGS. 142A-142D are each a top view of an alternative configuration fora delivery array and a sensing array associated with the infusionmonitor unit of FIG. 141;

FIG. 143 is a schematic side view of another exemplary configuration forthe delivery array and the sensing array associated with the infusionmonitor unit of FIG. 141;

FIG. 144 is a schematic side view of another exemplary configuration forthe delivery array and the sensing array associated with the infusionmonitor unit of FIG. 141;

FIG. 145A is a top view of another exemplary configuration for thedelivery array and the sensing array associated with the infusionmonitor unit of FIG. 141;

FIG. 145B is a side view of the configuration of FIG. 145A;

FIG. 146 is a schematic side view of another exemplary infusion monitorunit for measuring a physiological characteristic of a user, such as ablood glucose level, and for delivering a fluid to the user, which isassociated with an infusion set assembly and is for use with a fluidinfusion device, such as the fluid infusion device of FIG. 11;

FIG. 147 is a schematic side view of another exemplary infusion monitorunit for measuring a physiological characteristic of a user, such as ablood glucose level, and for delivering a fluid to the user, which isassociated with an infusion set assembly and is for use with a fluidinfusion device, such as the fluid infusion device of FIG. 11;

FIG. 148A is a top view of another exemplary infusion monitor unit formeasuring a physiological characteristic of a user, such as a bloodglucose level, and for delivering a fluid to the user, which isassociated with an infusion set assembly and is for use with a fluidinfusion device, such as the fluid infusion device of FIG. 11;

FIG. 148B is a side view of the infusion monitor unit of FIG. 148A;

FIG. 149 is a schematic side view of another exemplary infusion monitorunit for measuring a physiological characteristic of a user, such as ablood glucose level, and for delivering a fluid to the user, which isassociated with an infusion set assembly and is for use with a fluidinfusion device, such as the fluid infusion device of FIG. 11;

FIG. 150 is a schematic side view of another exemplary infusion monitorunit for measuring a physiological characteristic of a user, such as ablood glucose level, and for delivering a fluid to the user, which isassociated with an infusion set assembly and is for use with a fluidinfusion device, such as the fluid infusion device of FIG. 11;

FIG. 151 is a bottom view of the infusion monitor unit of FIG. 150; and

FIG. 152 is a schematic side view of another exemplary infusion monitorunit for measuring a physiological characteristic of a user, such as ablood glucose level, and for delivering a fluid to the user, which isassociated with an infusion set assembly and is for use with a fluidinfusion device, such as the fluid infusion device of FIG. 11.

DETAILED DESCRIPTION

The following detailed description is merely illustrative in nature andis not intended to limit the embodiments of the subject matter or theapplication and uses of such embodiments. As used herein, the word“exemplary” means “serving as an example, instance, or illustration.”Any implementation described herein as exemplary is not necessarily tobe construed as preferred or advantageous over other implementations.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

Certain terminology may be used in the following description for thepurpose of reference only, and thus are not intended to be limiting. Forexample, terms such as “top”, “bottom”, “upper”, “lower”, “above”, and“below” could be used to refer to directions in the drawings to whichreference is made. Terms such as “front”, “back”, “rear”, “side”,“outboard”, and “inboard” could be used to describe the orientationand/or location of portions of the component within a consistent butarbitrary frame of reference which is made clear by reference to thetext and the associated drawings describing the component underdiscussion. Such terminology may include the words specificallymentioned above, derivatives thereof, and words of similar import.Similarly, the terms “first”, “second”, and other such numerical termsreferring to structures do not imply a sequence or order unless clearlyindicated by the context.

As used herein, the term “axial” refers to a direction that is generallyparallel to or coincident with an axis of rotation, axis of symmetry, orcenterline of a component or components. For example, in a cylinder ordisc with a centerline and generally circular ends or opposing faces,the “axial” direction may refer to the direction that generally extendsin parallel to the centerline between the opposite ends or faces. Incertain instances, the term “axial” may be utilized with respect tocomponents that are not cylindrical (or otherwise radially symmetric).For example, the “axial” direction for a rectangular housing containinga rotating shaft may be viewed as a direction that is generally parallelto or coincident with the rotational axis of the shaft. Furthermore, theterm “radially” as used herein may refer to a direction or arelationship of components with respect to a line extending outward froma shared centerline, axis, or similar reference, for example in a planeof a cylinder or disc that is perpendicular to the centerline or axis.In certain instances, components may be viewed as “radially” alignedeven though one or both of the components may not be cylindrical (orotherwise radially symmetric). Furthermore, the terms “axial” and“radial” (and any derivatives) may encompass directional relationshipsthat are other than precisely aligned with (e.g., oblique to) the trueaxial and radial dimensions, provided the relationship is predominantlyin the respective nominal axial or radial direction. As used herein, theterm “transverse” denotes an axis that crosses another axis at an anglesuch that the axis and the other axis are neither substantiallyperpendicular nor substantially parallel.

As used herein, the term module refers to any hardware, software,firmware, electronic control component, processing logic, and/orprocessor device, individually or in any combination, including withoutlimitation: application specific integrated circuit (ASIC), anelectronic circuit, a processor (shared, dedicated, or group) and memorythat executes one or more software or firmware programs, a combinationallogic circuit, and/or other suitable components that provide thedescribed functionality.

Embodiments of the present disclosure may be described herein in termsof schematic, functional and/or logical block components and variousprocessing steps. It should be appreciated that such block componentsmay be realized by any number of hardware, software, and/or firmwarecomponents configured to perform the specified functions. For example,an embodiment of the present disclosure may employ various integratedcircuit components, e.g., memory elements, digital signal processingelements, logic elements, look-up tables, or the like, which may carryout a variety of functions under the control of one or moremicroprocessors or other control devices. In addition, those skilled inthe art will appreciate that embodiments of the present disclosure maybe practiced in conjunction with any number of systems, and that thefluid infusion device described herein is merely exemplary embodimentsof the present disclosure.

For the sake of brevity, conventional techniques related to signalprocessing, data transmission, signaling, control, and other functionalaspects of the systems (and the individual operating components of thesystems) may not be described in detail herein. Furthermore, theconnecting lines shown in the various figures contained herein areintended to represent example functional relationships and/or physicalcouplings between the various elements. It should be noted that manyalternative or additional functional relationships or physicalconnections may be present in an embodiment of the present disclosure.

The following description relates to various embodiments of a fluidinfusion device, such as for the treatment of diabetes, and to variousembodiments of an infusion set for coupling to the fluid infusion deviceto deliver fluid to an anatomy. The fluid infusion devices describedherein provide a reduced form factor and/or a simplified user interface,which may reduce complexity and cost while making it easier for the userto carry the fluid infusion device. In addition, infusion sets describedherein may reduce a number of insertion sites associated with the userby incorporating a continuous glucose sensor into the infusion set. Thenon-limiting examples described below relate to medical devices used totreat diabetes (such as an insulin pump and/or an infusion set),although embodiments of the disclosed subject matter are not so limited.Accordingly, the infused fluid is insulin in certain embodiments. Inalternative embodiments, however, many other fluids may be administeredthrough infusion such as, but not limited to, other disease treatments,drugs to treat pulmonary hypertension, iron chelation drugs, painmedications, anti-cancer treatments, other medications, vitamins, otherhormones, or the like. For the sake of brevity, conventional featuresand characteristics related to infusion system operation, insulin pumpand/or infusion set operation, fluid reservoirs, and fluid syringes maynot be described in detail here. Examples of infusion pumps and/orrelated pump drive systems used to administer insulin and othermedications may be of the type described in, but not limited to: U.S.Patent Publication Nos. 2009/0299290 and 2008/0269687; U.S. Pat. Nos.4,562,751; 4,678,408; 4,685,903; 5,080,653; 5,505,709; 5,097,122;6,485,465; 6,554,798; 6,558,351; 6,659,980; 6,752,787; 6,817,990;6,932,584; 7,621,893; 7,828,764; and 7,905,868; which are eachincorporated by reference herein. In addition, conventional aspects andtechnology related to glucose sensors, glucose sensor fabrication andthe determination of a glucose level or blood glucose level using aglucose sensor may not be described in detail here. In this regard,examples of glucose sensors and their manufacturing may be of the typedescribed in, but not limited to: U.S. Pat. Nos. 5,391,250, 6,892,085,7,468,033 and 9,295,786; and United States patent application number2009/0299301 (which are each incorporated by reference herein).

With reference to FIG. 1, FIG. 1 is a perspective view of a fluidinfusion device 100. In this example, the fluid infusion device 100includes a housing 102. Generally, the housing 102 has a small formfactor for portability, and is about 3 inches (in.) to about 4 inches(in.) long, about 1 inch (in.) to about 2 inches (in.) wide and is about0.5 inches (in.) to about 1.5 inches (in.) thick. The fluid infusiondevice 100 also generally weights less than about 80 grams (g). In someexamples, the housing 102 includes a first housing portion 103 and asecond housing portion 105, which are coupled together to form thehousing 102. In some examples, the first housing portion 103 of thehousing 102 is composed of a metal or metal alloy, such as aluminum,titanium, stainless steel, etc., and is formed via casting, stamping,additive manufacturing, etc. By forming the first housing portion 103 ofthe housing 102 using a metal or metal alloy, the first housing portion103 of the housing 102, which is larger than the second housing portion105, is resistant to environmental factors and chemical exposure, suchas water, sunscreen, etc. The use of a metal or metal alloy alsoprotects the fluid infusion device 100 from accidental drops, vibrationsand static loads during use, which improves reliability. Moreover, thesize and configuration of the housing 102 enables the fluid infusiondevice 100 to be carried more easily, and to be attached in differentorientations, such as lengthwise, via a clip, for example. Thus, thefluid infusion device 100 is sized and shaped to enable ease of use,which increases user satisfaction and convenience. In some examples, thehousing 102 has a largest dimension Dl and a smallest dimension Ds (FIG.3).

As shown in FIG. 1, the second housing portion 105 of the housing 102 isreceived within a channel 103 a of the first housing portion 103 suchthat the first housing portion 103 surrounds a majority of the secondhousing portion 105. The channel 103 a may include tabs 103 b, notchesor other guidance features to assist in coupling the first housingportion 103 to the second housing portion 105. The first housing portion103 may be coupled to the second housing portion 105 via laser welding,adhesives, mechanical fasteners, etc. In some examples, the firsthousing portion 103 defines a case, while the second housing portion 105forms a cover subassembly, which will be discussed in greater detailbelow.

With reference to FIG. 2, a bottom view including a user interface 104is shown. In this example, the user interface 104 includes a button 106and a light emitting element 108, such as a light emitting diode (LED).Notably, the user interface 104 is devoid of a display, which enables areduction in size and cost of the fluid infusion device 100. The button106 enables the user to turn the fluid infusion device 100 “off” or“on,” and also enables the user to clear alarms or alerts generated bythe fluid infusion device 100, reset or reboot the fluid infusion device100, provide a quick bolus, and to pair the fluid infusion device 100with a remote device or portable electronic device associated with theuser, such as the user's smart phone, tablet, smart watch, computer,continuous glucose monitor, etc. In this example, the light emittingelement 108 surrounds the button 106, however, the light emittingelement 108 may be positioned at other locations on the housing 102. Thelight emitting element 108 may be integrated with the button 106, or maybe coupled to the button 106 through any suitable technique, such aspress-fitting, adhesives, in-mold electronics, etc. In addition, incertain embodiments, the button 106 may be a cosmetic surface coupled toa force sensitive resistor (FSR) or a pressure sensor with a linearresonant actuator (LRA) that is programmed to vibrate and simulate theeffect of button presses. The light emitting element 108 provides avisual indicator of a status associated with the fluid infusion device100. For example, the light emitting element 108 may comprise amulticolor LED, which is controlled to illuminate in different colorsbased on a status of the fluid infusion device 100. For example, thelight emitting element 108 may be illuminated in green when the fluidinfusion device 100 is operating properly, may be illuminated in redwhen there is an alarm or alert associated with the fluid infusiondevice 100, may be illuminated in blue when pairing the fluid infusiondevice 100 with the user's portable electronic device, etc.

With reference to FIG. 3, the user interface 104 is generally disposedon one end 102 a of the housing 102, which is opposite an end 102 b ofthe housing 102 that encloses a drive system 110. The housing 102 alsoincludes opposed sides 102 c, 102 d, which cooperate with ends 102 a,102 b to enclose a power supply 112, a controller or control module 114,the drive system 110 and a fluid reservoir system 116. Generally, theside 102 c includes an opening 115 to receive a fluid reservoir (notshown). In this example, the power supply 112, the control module 114and the drive system 110 are accommodated in a pump chamber 113 aenclosed by the housing 102, and the fluid reservoir system 116 isaccommodated in a reservoir chamber 113 b enclosed by the housing 102.

The power supply 112 is any suitable device for supplying the fluidinfusion device 100 with power, including, but not limited to, abattery. In some examples, the power supply 112 is a rechargeablebattery, which is fixed within the housing 102. In this example, thepower supply 112 is a planar battery configured to supply power to thedrive system 110 that has a plurality of faces comprising one or morefaces 112 a having a largest area, and the planar battery is situatedsuch that the one or more faces 112 a, 112 b are parallel to the largestdimension Dl of the housing 102 (face 112 a) and the smallest dimensionDs of the housing 102 (face 112 b) (FIG. 4). The power supply 112 maycomprise a planar rectangular battery or a planar cylindrical battery.In such examples, the power supply 112 is rechargeable via USB, wirelesscharging, etc. In the example of USB charging, the housing 102 mayenclose a first charging device or USB port 118 to enable an electricalconnection between a USB receptacle 120 coupled to the control module114 of the fluid infusion device 100 and a remote charging source.Generally, the power supply 112 is chargeable for at least a 7-day use.

The control module 114 is in communication with the user interface 104,the power supply 112 and drive system 110. The control module 114 isalso in communication with the USB receptacle 120 to supply powerreceived to the power supply 112. The control module 114 controls theoperation of the fluid infusion device 100 based on user specificoperating parameters. For example, the control module 114 controls thesupply of power from the power supply 112 to the drive system 110 toactivate the drive system 110 to dispense fluid from the fluid reservoirsystem 116. Further detail regarding the control of the fluid infusiondevice 100 can be found in U.S. Pat. Nos. 6,485,465 and 7,621,893, therelevant content of which was previously incorporated herein byreference.

Briefly, the control module 114 includes at least one processor and acomputer readable storage device or media, which are mounted to aprinted circuit board 114 a like the one depicted in FIG. 4. The printedcircuit board 114 a is a rigid-flex printed circuit board that allowsthe flexible connections among the user interface 104, the power supply112, drive system 110, and the other components associated with thefluid infusion device 100 (such as the control module 114) and theprinted circuit board 114 a. The processor can be any custom made orcommercially available processor, a central processing unit (CPU), agraphics processing unit (GPU), an auxiliary processor among severalprocessors associated with the control module 114, a semiconductor basedmicroprocessor (in the form of a microchip or chip set), amacroprocessor, any combination thereof, or generally any device forexecuting instructions. In certain embodiments, the fluid infusiondevice 100 includes more than one processor, and includes a processordedicated to the drive system 110 to manage delivery of the fluid andmovement of the drive system 110. The computer readable storage deviceor media may include volatile and nonvolatile storage in read-onlymemory (ROM), random-access memory (RAM), and keep-alive memory (KAM),for example. KAM is a persistent or non-volatile memory that may be usedto store various operating variables while the processor is powereddown. The computer-readable storage device or media may be implementedusing any of a number of known memory devices such as PROMs(programmable read-only memory), EPROMs (electrically PROM), EEPROMs(electrically erasable PROM), flash memory, or any other electrical,magnetic, and/or optical memory devices capable of storing data, some ofwhich represent executable instructions, used by the control module 114in controlling components associated with the fluid infusion device 100.

The instructions may include one or more separate programs, each ofwhich comprises an ordered listing of executable instructions forimplementing logical functions. The instructions, when executed by theprocessor, may receive and process input signals; perform logic,calculations, methods and/or algorithms for controlling the componentsof the fluid infusion device 100; and generate signals to components ofthe fluid infusion device 100 to control the drive system 110 and/or thelight emitting element 108 based on the logic, calculations, methods,and/or algorithms Although only one control module 114 is shown,embodiments of the fluid infusion device 100 can include any number ofcontrol modules that communicate over any suitable communication mediumor a combination of communication mediums and that cooperate to processthe signals from the user interface 104; process signals received fromthe portable electronic device, perform logic, calculations, methods,and/or algorithms; and/or generate control signals to control featuresof the fluid infusion device 100.

In various embodiments, one or more instructions of the control module114, when executed by the processor, enable receiving and processingsignals from the user interface 104 to generate one or more controlsignals to the power supply 112 to supply power to the drive system 110,for example. Additionally, or alternatively, the one or moreinstructions of the control module 114, when executed by the processor,may enable receiving and processing signals from the user interface 104to generate one or more control signals to clear an alarm or alertassociated with the fluid infusion device 100. Additionally, oralternatively, the one or more instructions of the control module 114,when executed by the processor, may enable receiving and processingsignals from the user interface 104 to generate one or more controlsignals to wirelessly pair the portable electronic device associatedwith the user with the fluid infusion device 100. Additionally, oralternatively, the one or more instructions of the control module 114,when executed by the processor, enable receiving and processing signalsreceived from the portable electronic device, to generate one or morecontrol signals to the power supply 112 to supply power to the drivesystem 110.

In certain instances, the control module 114 is in communication with anantenna 122 like the one depicted in FIG. 4. In some examples, theantenna 122 is a laser direction structure antenna, which iselectrically and mechanically coupled to the printed circuit board 114 aof the control module 114. It should be noted, however, that the antenna122 may comprise any suitable antenna 122 that enables bi-directionalcommunication between the fluid infusion device 100 and the portableelectronic device of the user. Thus, generally, the antenna 122 enableswireless communication between the fluid infusion device 100 and anotherdevice, including, but not limited to, an infusion pump, handheld device(tablet, smart phone, etc.) and/or a monitoring device. In someexamples, the antenna 122 may include, but is not limited to, anear-field communication (NFC) antenna, a radio frequency (RF)communication antenna, a far-field communication antenna, a wirelesscommunication system configured to communicate via a wireless local areanetwork (WLAN) using Institute of Electrical and Electronics Engineers(IEEE) 802.11 standards or by using cellular data communication, aBLUETOOTH antenna, etc. In certain embodiments, the antenna 122 of thefluid infusion device 100 may include more than one communicationdevice, such as a near-field communication (NFC) antenna and a BLUETOOTHlow energy (BLE) trace antenna.

In some examples, a bracket 124 is positioned between the power supply112 and the printed circuit board 114 a of the control module 114. Thebracket 124 provides a mounting location for the power supply 112, andassists in securing the printed circuit board 114 a to the secondhousing portion 105 of the housing 102. The bracket 124 may be composedof a polymeric material, and may be molded, additive manufactured, etc.With reference to FIG. 4, the bracket 124 includes a first mounting end124 a, a second mounting end 124 b opposite the first mounting end 124 aand includes or defines a slot 124 c.

The first mounting end 124 a is coupled to the printed circuit board 114a. The first mounting end 124 a is also coupled to a vibration motor126. The vibration motor 126 is electrically coupled to the printedcircuit board 114 a to be in communication with the control module 114.The vibration motor 126 is responsive to one or more signals from thecontrol module 114 to vibrate, which causes a vibration of the housing102. The vibration of the housing 102 provides a tactile alert, alarm ornotification to the user. The vibration motor 126 may be a rotary orlinear resonant actuator. The use of a linear resonant actuators mayalso provide qualitative haptics as additional feedback mechanisms tothe user.

The second mounting end 124 b is coupled to the printed circuit board114 a and at least partially surrounds the USB receptacle 120. The slot124 c is sized to accommodate the power supply 112 and to retain thepower supply 112 within the housing 102. The first mounting end 124 aand the second mounting end 124 b may be coupled to the printed circuitboard 114 a via one or more mechanical fasteners, which extend throughthe printed circuit board 114 a and engage with the second housingportion 105 of the housing 102, as will be discussed below.

Referring back to FIG. 3, the drive system 110 cooperates with the fluidreservoir system 116 to dispense the fluid from the fluid reservoirsystem 116. In some examples, the drive system 110 includes a motor 130,a gear box 132, a drive screw 134, a slide 136 and a force sensor 138.The motor 130 receives power from the power supply 112 as controlled bythe control module 114. In some examples, the motor 130 is an electricmotor. The motor 130 includes an output shaft 130 a. The output shaft130 a is coupled to the gear box 132. In some embodiments, the gear box132 is a reduction gear box. The gear box 132 enables the fluid infusiondevice 100 to be controlled to deliver different concentrations offluid. The gear box 132 includes an output shaft 132 a, which is coupledto the drive screw 134.

The drive screw 134 includes a generally cylindrical distal portion 140and a generally cylindrical proximal portion 142. The distal portion 140has a diameter, which is larger than a diameter of the proximal portion142. The distal portion 140 includes a plurality of threads 140 a. Theplurality of threads 140 a are generally formed about an exteriorcircumference of the distal portion 140. The proximal portion 142 isgenerally unthreaded and can be sized to be received within a portion ofthe slide 136. The proximal portion 142 can serve to align the drivescrew 134 within the slide 136 during assembly, for example.

With continued reference to FIG. 3, the slide 136 is substantiallycylindrical and includes a distal slide end 144, a proximal slide end146 and a plurality of threads 148. The distal slide end 144 is adjacentto the motor 130 when the slide 136 is in a first, fully retractedposition and the proximal slide end 146 is adjacent to the drive screw134 when the slide 136 is in the first, fully retracted position. Theproximal slide end 146 includes a projection 150 and a shoulder 152,which cooperate with the fluid reservoir system 116 to dispense thefluid from the fluid reservoir system 116. The shoulder 152 is definedadjacent to the projection 150 and contacts a portion of the fluidreservoir system 116 to dispense fluid from the fluid reservoir system116.

The plurality of threads 148 of the slide 136 are formed along aninterior surface 136 a of the slide 136 between the distal slide end 144and the proximal slide end 146. The plurality of threads 148 are formedso as to threadably engage the threads 140 a of the drive screw 134.Thus, the rotation of the drive screw 134 causes the linear translationof the slide 136.

In this regard, the slide 136 is generally sized such that in a first,retracted position, the motor 130, the gear box 132 and the drive screw134 are substantially surrounded by the slide 136 as shown in FIG. 3.The slide 136 is movable to a second, fully extended position throughthe operation of the motor 130. The slide 136 is also movable to aplurality of positions between the first, retracted position and thesecond, fully extended position via the operation of the motor 130.Generally, the operation of the motor 130 rotates the output shaft 130a, which is coupled to the gear box 132. The gear box 132 reduces thespeed and increases the torque output by the motor 130, and the outputshaft 132 a of the gear box 132 rotates the drive screw 134, which movesalong the threads 148 formed within the slide 136. The movement orrotation of the drive screw 134 relative to the slide 136 causes themovement or linear translation of the slide 136 within the housing 102.The forward advancement of the slide 136 (i.e., the movement of theslide 136 toward the fluid reservoir system 116) causes the fluidreservoir system 116 to dispense fluid.

The force sensor 138 is operatively associated with the drive system 110and is in communication with the control module 114. In some examples,with reference to FIG. 5, the force sensor 138 is coupled to the drivesystem 110, and it is located between the motor 130 and the secondhousing portion 105 of the housing 102. In some configurations, theforce sensor 138 is affixed to the second housing portion 105 such thatthe force sensor 138 reacts when the motor 130 bears against the forcesensor 138. This configuration and arrangement of the motor 130 and theforce sensor 138 allows the force sensor 138 to react to forces impartedthereto by the drive system 110 and/or forces imparted to the drivesystem 110 via a fluid pressure associated with the fluid reservoirsystem 116. In some other configurations, the force sensor 138 may beaffixed to the motor 130 such that the force sensor 138 reacts when itbears against the second housing portion 105.

Further details regarding the features and operation of the force sensor138 are found in commonly assigned U.S. Pat. No. 8,628,510, the relevantportion of which is incorporated by reference. Generally, the forcesensor 138 is used to detect when the slide 136 contacts a portion ofthe fluid reservoir system 116, to detect when the force sensor 138needs calibration, to detect when the force sensor 138 is not operatingwithin a normal operating range, to detect when an occlusion is presentin a fluid flow path defined by the fluid reservoir system 116 and/or todetermine whether a fluid reservoir 160 associated with the fluidreservoir system 116 may be properly seated and installed. As will bediscussed further herein, the force sensor 138 is coupled to the secondhousing portion 105 such that the force sensor 138 is not pre-loaded oris minimally preloaded to a preset value.

With continued reference to FIG. 5, the fluid reservoir system 116includes the fluid reservoir 160 and a sealing member 162. The sealingmember 162 is situated between the fluid reservoir 160 and the drivesystem 110 to prevent the ingress of fluids into the pump chamber 113 aof the housing 102. In some examples, the sealing member 162 comprisesan O-ring; however, any suitable device can be used to prevent theingress of fluids, as known to one skilled in the art.

The fluid reservoir 160 can be inserted into the opening 115 defined inthe housing 102. The fluid reservoir 160 is removable from the housing102 to enable replacement as needed. Thus, the housing 102 is configuredto accommodate the fluid reservoir 160, which is removable. The fluidreservoir 160 includes a body or barrel 164 and a stopper 166. Thebarrel 164 has a first or distal barrel end 168 and a second or proximalbarrel end 170. Fluid is retained within the barrel 164 between thedistal barrel end 168 and the proximal barrel end 170. The distal barrelend 168 is positioned adjacent to the slide 136 when the fluid reservoir160 is inserted into the opening 115 of the housing 102. Generally, thedistal barrel end 168 has a substantially open perimeter or issubstantially circumferentially open such that the slide 136 isreceivable within the barrel 164 through the distal barrel end 168.Generally, the slide 136 is interoperable with the fluid reservoir 160at the distal barrel end 168 (e.g., the distal barrel end 168 mayinclude an opening that can accommodate at least part of the slide 136within the barrel 164).

The proximal barrel end 170 can have any suitable size and shape formating with at least a portion of an infusion set assembly 300, as willbe discussed in further detail herein. In some examples, the proximalbarrel end 170 defines a passageway 172 through which the fluid flowsout of the fluid reservoir 160. The passageway 172 may be closed by aseptum (not shown). The septum may be positioned within a portion of theproximal barrel end 170, and is coupled to the proximal barrel end 170through any suitable technique, such as ultrasonic welding, press-fit,etc. The septum serves as a barrier to prevent the ingress of fluidsinto the fluid reservoir 160, and prevents the egress of fluids from thefluid reservoir 160. The septum is pierceable by the infusion setassembly 300 to define a fluid flow path out of the fluid reservoir 160.In some examples, the infusion set assembly 300 includes a connector302, a hollow instrument or needle 304 and the tube 306. The connector302 couples the needle 304 and the tube 306 to the fluid reservoir 160,and locks into place once coupled to the fluid reservoir 160 to maintainthe fluid flow path between the fluid reservoir 160 and an infusion unit308. The connector 302 may be a removable reservoir cap (or fitting)that is suitably sized and configured such that the connector 302 can beseparated from the fluid reservoir 160 when the fluid reservoir 160(which is typically disposable) is to be replaced. The needle 304defines a flow path for the fluid out of the fluid reservoir 160,through the connector 302 and into the tube 306.

With reference to FIG. 3, the stopper 166 is disposed within the barrel164. The stopper 166 is movable within and relative to the barrel 164 todispense fluid from the fluid reservoir 160. When the barrel 164 is fullof fluid, the stopper 166 is adjacent to the distal barrel end 168, andthe stopper 166 is movable to a position adjacent to the proximal barrelend 170 to empty the fluid from the fluid reservoir 160. In someexamples, the stopper 166 is substantially cylindrical, and includes afirst stopper end 174, a second stopper end 176, at least one frictionelement and a counterbore 180 defined from the first stopper end 174 tothe second stopper end 176.

The first stopper end 174 is open about a perimeter of the first stopperend 174, and thus, is generally circumferentially open. The secondstopper end 176 is closed about a perimeter of the second stopper end176, and thus, is generally circumferentially closed. The second stopperend 176 includes a slightly conical external surface, however, thesecond stopper end 176 can be flat, convex, etc. The at least onefriction element is coupled to the stopper 166 about an exterior surfaceof the stopper 166. In some examples, the at least one friction elementcomprises two friction elements, which include, but are not limited to,O-rings. The friction elements are coupled to circumferential groovesdefined in the exterior surface of the stopper 166. The counterbore 180receives the projection 150 of the slide 136 and the movement of theslide 136 causes the shoulder 152 of the slide 136 to contact and movethe stopper 166. Generally, the drive system 110 is configured to beserially coupled to the removable fluid reservoir 160 such that acombined dimension of the drive system 110 and the removable fluidreservoir 160 is less than or equal to the largest dimension Dl (FIG.3).

As discussed, the second housing portion 105 forms a cover subassemblyand cooperates with the first housing portion 103 to enclose the fluidinfusion device 100. With reference to FIG. 6, the second housingportion 105 is shown in greater detail. FIG. 6 is an exploded view ofthe second housing portion 105. The second housing portion 105 includesa frame 184, a second charging device or charging coil 186, a sealingmember 188 and a cover 190. The frame 184 is composed of a metal ormetal alloy, such as aluminum, stainless steel, titanium, and isstamped, cast, additive manufactured, etc. By forming the frame 184 of ametal or metal alloy, the frame 184 provides strength for the secondhousing portion 105. The frame 184 includes a first frame end 192opposite a second frame end 194, and a first frame side 196 opposite asecond frame side 198. The first frame end 192 is coupled to the cover190, and assists in absorbing shocks and loads when the fluid infusiondevice 100 is mishandled, for example. As will be discussed, the firstframe end 192 includes a tab 192 a. The tab 192 a projects into a recessdefined along the first frame end 192 to enable the tab 192 a to engagethe cover 190. The tab 192 a forms a mechanical interlock with the cover190, which immobilizes the frame 184 on the cover 190. The second frameend 194 may be coupled to the cover 190, and may extend for a distancefrom the first frame side 196 that is greater than the first frame end192. The second frame end 194 includes a bore 200, a lip 202 and arelief 204. As will be discussed, the bore 200 receives a force sensornut 206 (FIG. 4) for coupling the force sensor 138 to the frame 184. Thelip 202 cooperates with an undercut 208 (FIG. 5) on the first housingportion 103 to assist in coupling the first housing portion 103 to thesecond housing portion 105, as will also be discussed. The relief 204enables the frame 184 to be positioned about the antenna 122. Generally,the frame 184 enables ease of manufacturing. In this regard, componentscan be assembled onto the frame 184 in a relatively open construct whichallows easy access and limits compromise or damage of the user-facingoutside surfaces with inadvertent nicks, scratches, etc. duringmanufacturing.

The first frame side 196 is positioned adjacent to the printed circuitboard 114 a (FIG. 5) and the second frame side 198 is positionedadjacent to the cover 190. In some examples, the frame 184 is coupled tothe cover 190 via at least one or a plurality of heat stakes 191;however, any suitable technique may be employed to couple the frame 184to the cover 190, such as adhesives, mechanical fasteners, etc. A bore195 is defined through the first frame side 196 and the second frameside 198 to enable electrical communication between the user interface104 and the printed circuit board 114 a. A slit 184 a is defined betweenthe first frame side 196 and the second frame side 198 to enableelectrical communication between the charging coil 186 and the printedcircuit board 114 a. The slit 184 a is in communication with or adjacentto a slot 197 defined through first frame side 196 and the second frameside 198. The slot 197 receives the USB receptacle 120 (FIG. 5). Theframe 184 may also include raised portions 184 b, 184 c, which cooperatewith the cover 190. In some examples, the raised portion 184 binterfaces with the cover 190 to accommodate the sealing member 188 andthe user interface 104; and the raised portion 184 c cooperates with thecover 190 to enable electrical communication between the charging coil186 and the printed circuit board 114 a. The frame 184 also includes aplurality of threaded bores 193, which receive a respective mechanicalfastener, such as a screw, to couple the bracket 124 to the frame 184(FIG. 4).

The charging coil 186 is positioned between the frame 184 and the cover190. The charging coil 186 is electrically coupled to the printedcircuit board 114 a via the slit 184 a defined in the frame 184, and thecharging coil 186 is in communication with the control module 114. Thecharging coil 186 enables a user to wirelessly charge the fluid infusiondevice 100. The charging coil 186 may comprise any suitable chargingcoil that enables the charging of the power supply 112. The chargingcoil 186 is configured and oriented in such a way that it charges withthe greatest efficiency, thereby reducing the time to charge. Theorientation of the charging coil 186 within the frame 184 is such thatthe fluid infusion device 100 may be set down onto a charging pad forgeneral charging, or may be set into a form-fitting wireless chargingreceptacle with predetermined positioning. This charging receptacle may,itself, be battery powered and can slip over the fluid infusion device100 for charging while on the go such that the fluid infusion device 100remains functional during charging.

The sealing member 188 surrounds the user interface 104 and forms a sealbetween the user interface 104 and the cover 190. In some examples, thesealing member 188 is composed of an elastomeric, semi-solid, orsimilarly compliant material, including, but not limited to silicone,ethylene propylene diene terpolymer (EPDM), Polytetrafluoroethylene(PTFE), synthetic or natural rubbers, or fluoropolymer. Alternatively,sealing may be accomplished by means of a material exhibiting orcomprising a high surface tension in combination with a gap betweencomponents that in combination do not allow the ingress of water or dustup to the levels anticipated with the fluid infusion device 100, forexample, about 8 to about 12 feet for water and dust, such as thatassociated with an IP58 rating. Generally, the sealing member 188 isclear, however, the sealing member 188 may have any desired color. Insome examples, the sealing member 188 is overmolded around the userinterface 104. With reference to FIG. 7, an end view of the secondhousing portion 105 is shown. As shown, the frame 184 is coupled to thecover 190 so as to sandwich the sealing member 188 and the charging coil186 between the frame 184 and the cover 190. With reference to FIG. 8, aside view of the second housing portion 105 is shown. As shown in FIG.8, the sealing member 188 includes a first member end 210 opposite asecond member end 212 and a central bore 188 a. The central bore 188 aenables receipt of the user interface 104 and electrical connection tothe printed circuit board 114 a to place the user interface 104 incommunication with the control module 114. The first member end 210extends outwardly from the central bore 188 a, and the first member end210 is coupled to the frame 184 and the cover 190 such that the secondmember end 212 is movable or compressible relative to the first memberend 210 to enable the user to depress the button 106. In this example,material is removed between the first member end 210 and the secondmember end 212 to define a gap 213 (FIG. 9) between the first member end210 and the second member end 212, which enables the movement of thebutton 106 relative to the second housing portion 105 of the housing102.

The second member end 212 is annular, and is sized to receive andsurround the user interface 104. The first member end 210 includes anannular sealing flange 214, which extends outwardly from the centralbore 188 a. The annular sealing flange 214 may be bulbous at a terminalend 210 a to assist in forming the seal between the frame 184 and thecover 190. With reference to FIG. 9, FIG. 9 is a detail view of FIG. 8.As shown in FIG. 9, the coupling of the frame 184 to the cover 190compresses the sealing member 188 to form a hermetic seal between thehousing 102 and the user interface 104. The hermetic seal inhibits theflow of fluids or other debris into the housing 102, which protects theinternal components of the housing 102.

With reference back to FIG. 6, the cover 190 forms part of an exteriorsurface of the housing 102. The cover 190 is composed of a polymericmaterial, such as polycarbonate (PC), polybutylene succinate (PBS),acrylonitrile butadiene styrene (ABS), polypropylene (PP), nylon,polyethylene (PE), polyethylene terephthalate (PET, PETG), polyvinylchloride (PVC), or blends thereof, and is molded, cast, additivemanufactured, etc. By composing the cover 190 of a polymeric material,the cover 190 enables radio frequencies to pass through the housing 102and also allows a magnetic field to pass through the housing 102.Alternatively, it should be noted that the first housing portion 103 andthe cover 190 may be composed of the same metal or metal alloy, and arecoupled together via welding, adhesives, etc. The cover 190 includes afirst cover end 220 opposite a second cover end 222, and a first coverside 224 opposite a second cover side 226. The first cover end 220 iscoupled to the first frame end 192. In some examples, with reference toFIG. 9, the first cover end 220 includes or defines a slot 228. The slot228 receives the tab 192 a of the frame 184 to mechanically couple theframe 184 to the cover 190.

With reference to FIG. 8, the second cover end 222 includes or defines afirst bore 230 and a second bore 232, which circumscribes the first bore230. The second cover end 222 is also overmolded over the antenna 122.The first bore 230 is sized to receive the force sensor nut 206, and thesecond bore 232 is sized to receive an end plate 238. The first bore 230generally has a diameter, which is different and smaller than the secondbore 232. With reference to FIG. 10, a detail view of the second coverend 222 is shown. As shown, the force sensor nut 206 is received throughthe first bore 230 and the bore 200 of the frame 184 and is threadablycoupled to the force sensor 138. In this example, the force sensor nut206 is threaded onto a pin 138 a of the force sensor 138. The threadedconnection between the force sensor nut 206 and pin 138 a of the forcesensor 138 may eliminate any clearance at the interface between theforce sensor 138 and the second housing portion 105 without introducingany preload on force sensor 138.

The end plate 238 is composed of a polymeric material, including, butnot limited to polycarbonate (PC), polybutylene succinate (PBS),acrylonitrile butadiene styrene (ABS), polypropylene (PP), nylon,polyethylene (PE), polyethylene terephthalate (PET, PETG), polyvinylchloride (PVC), or blends thereof. The end plate 238 is coupled to theforce sensor nut 206 to inhibit the force sensor nut 206 from backingout during the use of the fluid infusion device 100. The end plate 238is circular, however, the end plate 238 may have any desired shape. Insome examples, with reference to FIG. 4, the end plate 238 includes aninner bore 240 and a plate sealing member 242. The inner bore 240defines a shape about a circumference of the inner bore 240 thatcorresponds with a shape of a perimeter or circumference of the forcesensor nut 206. In this example, the inner bore 240 defines a hexagonalshape, which corresponds with a hexagonal head 206 a of the force sensornut 206. By providing the inner bore 240 with a shape that matches ashape of the head 206 a of the force sensor nut 206, relative rotationbetween the force sensor nut 206 and the end plate 238 is inhibited. Theplate sealing member 242 may be composed of a polymeric material, suchas an elastomeric material, which is overmolded about an outer perimeteror circumference of the end plate 238. The plate sealing member 242provides a hermetic seal between the force sensor nut 206 and the cover190.

With reference back to FIG. 6, the cover 190 may also include a sealingmember 244, which extends about a perimeter of the cover 190. Thesealing member 244 may contact the first housing portion 103 and mayform a seal between the first housing portion 103 and the second housingportion 105. The sealing member 244 may be composed of a suitablepolymeric material, such as an elastomeric material, which may beovermolded on the cover 190 or coupled to the cover 190 via ultrasonicwelding, adhesives, press-fit into a groove 244 a defined about theperimeter of the cover 190, etc.

With reference back to FIG. 6, the first cover side 224 defines a userinterface receptacle 246, a charging coil slot 248 and a port receptacle250. The user interface receptacle 246 includes a bore 246 a (FIG. 9),which is defined through the cover 190 from the first cover side 224 tothe second cover side 226. The user interface receptacle 246 includes acircumferential recess 246 b, which is defined about the bore 246 a.With reference to FIG. 9, the circumferential recess 246 b receives theannular sealing flange 214 of the sealing member 188. In this example,the circumferential recess 246 b is defined so as to be spaced apartfrom the bore 246 a to form a lip 246 c about a perimeter of the bore246 a. The lip 246 c assists in assembly of the sealing member 188 tothe cover 190.

With reference back to FIG. 6, the charging coil slot 248 is recessedwithin the first cover side 224 and is sized to receive the chargingcoil 186. The port receptacle 250 is defined between adjacent sidewalls224 a of the first cover side 224, and is sized to receive and supportthe USB receptacle 120 (FIG. 5) within the cover 190. The second coverside 226 is generally smooth, as shown in FIG. 3.

With continued reference to FIG. 3, in some examples, with the slide136, the drive screw 134, the gear box 132 and the motor 130 formed, themotor 130 is coupled to the gear box 132 and the drive screw 134 iscoupled to the gear box 132. The slide 136 is positioned over the drivescrew 134 and the threads 134 a of the drive screw 134 threadably engagethe threads 140 a of the slide 136. With the first housing portion 103of the housing 102 formed, the sealing member 162 is positioned in thefirst housing portion 103 and the assembled drive system 110 is coupledto the first housing portion 103 of the housing 102. The force sensor138 is positioned within the first housing portion 103 and electricallyconnected to the printed circuit board 114 a to be in communication withthe control module 114. With reference to FIG. 6, with the cover 190formed, the charging coil 186 is coupled to the cover 190. The sealingmember 188 is overmolded onto the user interface 104, and the sealingmember 188, with the user interface 104, is positioned within the userinterface receptacle 246. The frame 184 is coupled to the cover 190 suchthat the tab 192 a engages the slot 228 and the frame 184 compresses theterminal end 210 a of the sealing member 188. The frame 184 is thencoupled to the cover 190 via one or more heat stakes 191, for example.

With reference to FIG. 4, with the control module 114 and the USBreceptacle 120 coupled to and in communication with the printed circuitboard 114 a, the printed circuit board 114 a is coupled to the secondhousing portion 105. The user interface 104 and the charging coil 186are electrically coupled to the printed circuit board 114 a and placedin communication with the control module 114. The bracket 124 ispositioned over the printed circuit board 114 a and coupled to the frame184 via one or more mechanical fasteners received in the bores 193, forexample. The power supply 112 is positioned on the bracket 124 andelectrically coupled to the printed circuit board 114 a to be incommunication with the control module 114. The vibration motor 126 iscoupled to the bracket 124, and the vibration motor 126 is electricallycoupled to the printed circuit board 114 a to be in communication withthe control module 114. The second housing portion 105 is coupled to thefirst housing portion 103.

In some examples, with reference to FIG. 10, the second housing portion105 of the housing 102 is positioned such that the lip 202 of the frame184 engages with the undercut 208 of the first housing portion 103. Thecontact between the lip 202 and the undercut 208 forms a snap-fit. Asthe engagement between the lip 202 and the undercut 208 is springloaded, the lip 202 maintains contact with the undercut 208 of the firsthousing portion 103 to couple the second housing portion 105 with thefirst housing portion 103. Generally, the undercut 208 is defined suchthat an angle on the surface of the undercut 208 is smaller than afriction angle between the lip 202 and the first housing portion 103.The lip 202 and the undercut 208 cooperate to eliminate clearancebetween the first housing portion 103 and the second housing portion 105during assembly. With the second housing portion 105 coupled to thefirst housing portion 103, the force sensor nut 206 is coupled to thepin 138 a of the force sensor 138. The end plate 238 is coupled to theforce sensor nut 206 to surround the force sensor nut 206 and isreceived within the second bore 232 of the cover 190.

With the fluid infusion device 100 assembled, the fluid infusion device100 may be packaged and shipped to an end user. Once received, the enduser may remove the packaging and with reference to FIG. 5, the user maycouple the fluid reservoir 160 to the housing 102 by positioning thefluid reservoir 160 within the opening 115 defined in the housing 102.Generally, the fluid reservoir 160 is prefilled with fluid, in thisexample, insulin, such that the stopper 166 is positioned at the distalbarrel end 168. The connector 302 is coupled to the fluid reservoir 160prior to insertion of the fluid reservoir 160 into the housing 102 forease of handling by the user. With the infusion set assembly 300 fixedlycoupled or secured to the housing 102, the needle 304 pierces theseptum, thereby defining a fluid flow path for the fluid out of thefluid reservoir 160. With the infusion set assembly 300 coupled to thefluid reservoir 160 and the infusion unit 308 coupled to the anatomy ofthe user, one or more control signals from the control module 114 candrive the motor 130, thereby rotating the drive screw 134, which resultsin the linear translation of the slide 136. The advancement of the slide136 into the fluid reservoir 160 moves the stopper 166, causing thefluid to flow from the fluid reservoir 160 through the fluid flow pathdefined by the infusion set assembly 300.

It should be noted that the fluid infusion device 100 may also beconfigured to draw fluid, such as insulin, from a vial into the fluidreservoir 160 autonomously instead of from pre-filled fluid reservoirs160. It should be noted that the shape of the fluid reservoir 160 foruse with the fluid infusion device 100 allows for a very even sealpressure within the fluid reservoir 160, thereby reducing leaks in thefluid reservoir system 116. The cylindrical shape of the fluid reservoir160 is also easier to manufacture at high volumes for a reduced cost dueto the inherent symmetry in the design.

In addition, the fluid infusion device 100 may include accelerometers incommunication with the control module 114 to track movement of the fluidinfusion device 100 to measure and confirm gestures for functions of thefluid infusion device 100. For example, a particular movement of thefluid infusion device 100 may be observed/measured by the accelerometer,and the control module 114 may output one or more control signals totrigger pairing, quick bolus, confirm bolus, query pump status, etc.based on a detected movement with notifications output to the user viaone or more control signals to the vibration motor 126. In addition, thefluid infusion device 100 may include a sensor that detects a presenceof a magnetic field, which is in communication with the control module114, and the control module 114 may determine whether an infusion set iscoupled to the fluid infusion device 100 based on the sensor signalsfrom the sensor. The fluid infusion device 100 may also include othercommunication devices to enable the fluid infusion device 100 tocommunicate with infusion sets or other devices to enable the fluidinfusion device 100 to automate priming, fill tubing and fill a cannulabased on received communications and sensor signals from the forcesensor 138. For example, the fluid infusion device 100 may include amagnetic field sensor in communication with the control module 114,which observes a magnetic field generated by a magnet coupled to theinfusion set assembly 300, such as the connector 302, to determine thetype of infusion set assembly 300 coupled to the fluid infusion device100. For example, an infusion set assembly may include a tube 306 thatis longer or shorter than another infusion set assembly, and the controlmodule 114 may process the signals from the magnetic field sensor anddetermine which infusion set assembly (long tube, short tube) is coupledto the fluid infusion device 100.

It should be noted that configurations of, the fluid infusion device 100may vary from implementation to implementation. For example, withreference to FIG. 11, a portable fluid infusion device 400 is shown. Asthe fluid infusion device 400 includes the same or similar components asthe fluid infusion device 100 discussed with regard to FIGS. 1-10, thesame reference numerals will be used to denote the same or similarcomponents. FIG. 11 is a perspective view of the fluid infusion device400, and FIG. 12 is an end view. The fluid infusion device 400 may beused with the infusion set assembly 300 or other devices, as will bediscussed in further detail below.

In the examples of FIGS. 11 and 12, the fluid infusion device 400includes a housing 402. Generally, the housing 402 has a small formfactor for portability, and is about 10 millimeters (mm) to about 20millimeters (mm) thick, about 20 millimeters (mm) to about 30millimeters (mm) wide and is about 75 millimeters (mm) to about 85millimeters (mm) long. Thus, the housing 402 has a largest dimension DL4(FIG. 11) and a smallest dimension DS4 (FIG. 12). In some examples, thehousing 402 includes a first housing portion 404 and a second housingportion 406, which are coupled together to form the housing 402. Thefirst housing portion 404 and the second housing portion 406 are eachcomposed of a polymeric material, including, but not limited topolycarbonate, and may be molded, additively manufactured, etc.Generally, with reference to the example of FIG. 13, the first housingportion 404 and the second housing portion 406 cooperate to enclose apower supply 420, a controller or control module 422, the drive system110 and the fluid reservoir system 116. In this example, the fluidinfusion device 400 is devoid of a user interface.

In some examples, with reference back to FIGS. 11 and 12, the firsthousing portion 404 and the second housing portion 406 are coupledtogether in a manner that forms a seal at an interface 408 between thefirst housing portion 404 and the second housing portion 406. In theseexamples, the first housing portion 404 and the second housing portion406 are coupled together via welding, including, but not limited tolaser welding, ultrasonic welding, radiofrequency welding, etc. Incertain embodiments, the first housing portion 404 and the secondhousing portion 406 may each have alignment features defined along theinterface 408, which assist in coupling the first housing portion 404 tothe second housing portion 406. For example, one of the first housingportion 404 and the second housing portion 406 may include male posts atthe interface, and the other of the first housing portion 404 and thesecond housing portion 406 may include corresponding female posts sothat the first housing portion 404 and the second housing portion 406are aligned prior to welding.

In certain instances, such as in the instance of coupling the firsthousing portion 404 and the second housing portion 406 together vialaser welding, the second housing portion 406 is made of transparentpolymeric material, while the first housing portion 404 is made ofopaque polymeric material (or vice versa). This allows the laser beam topass through the transparent polymeric material and heat up the opaquepolymeric material at the interface 408 with the transparent polymericmaterial, and thus, melt/weld the two materials together at theinterface 408. Additionally, or alternatively, the first housing portion404 and the second housing portion 406 may be coupled together via anadhesive applied at the interface 408. Additionally, or alternatively,the first housing portion 404 and the second housing portion 406 may becoupled together via a snap fit, with snap fit engagement featuresdefined along the interface 408. Additionally, or alternatively, thefirst housing portion 404 and the second housing portion 406 may becoupled together via one or more mechanical fasteners, such as screws.As will be discussed, in some examples, the second housing portion 406defines a coupling slot 414, which enables the fluid infusion device 400to be coupled to an anatomy.

The housing 402, when assembled, includes opposed sides 402 a, 402 b,and opposed ends 402 c, 402 d. Generally, the end 402 c defines anopening 410 to receive the fluid reservoir 160. Generally, the powersupply 420, the control module 422 and the drive system 110 areaccommodated in a pump chamber 412 a defined by the housing 402, and thefluid reservoir system 116 is accommodated in a reservoir chamber 412 bdefined by the housing 402. With reference to FIG. 14, a top view of thefluid infusion device 400 is shown. With reference to FIG. 15, in orderto provide waterproofing or to inhibit fluids from flowing from thereservoir chamber 412 b to the pump chamber 412 a, a sealing member 416may be situated between the pump chamber 412 a and the reservoir chamber412 b. The sealing member 416, in some examples, is an O-ring, which iscomposed of an elastomeric material, including, but not limited torubber, nitrile, silicone, polyurethane, synthetic or natural rubbers,etc. The sealing member 416 is positioned about the motor 130. Bypositioning the sealing member 416 about the motor 130, a fluid pathfrom an external environment is blocked by the sealing member 416, whichinhibits fluid from reaching the pump chamber 412 a including thecomponents contained in the pump chamber 412 a, such as the controlmodule 422, power supply 420, etc.

Generally, with reference to FIG. 16, the sealing member 416 iscompressed by the first housing portion 404 on one side and by thesecond housing portion 406 on the other side. With reference to FIG.17A, this causes the sealing member 416, which is elastic, to expandoutward and fill an area defined between the first housing portion 404and the second housing portion 406. As the interface 408 between thefirst housing portion 404 and the second housing portion 406 is welded,the sealing member 416 inhibits fluid from the external environment fromentering the pump chamber 412 a, thereby waterproofing the fluidinfusion device 400. The first housing portion 404 and the secondhousing portion 406 each include an internal flange 418 (FIGS. 16 and17B), which extends outward from the respective one of the first housingportion 404 and the second housing portion 406. The flange 418 ensuresthat the sealing member 416 is retained adjacent to the motor 130 whencompressed by the first housing portion 404 and the second housingportion 406, as shown in FIG. 17B. With reference to FIG. 17C, the slide136 also cooperates with the first housing portion 404 and the secondhousing portion 406 to inhibit a flow of fluid toward the sealing member416.

With reference back to FIG. 13, the power supply 420 is any suitabledevice for supplying the fluid infusion device 400 with power,including, but not limited to, a battery. In some examples, the powersupply 420 is a rechargeable battery, which is fixed within the housing402 (FIG. 14). In some embodiments, the power supply 420 is rechargeablevia wireless charging, etc. The power supply 420 is a planar batteryconfigured to supply power to the fluid infusion device 400 that has aplurality of faces comprising one or more faces 420 a having a largestarea, and the planar battery is situated such that the one or more faces420 a, 420 b are parallel to the largest dimension D14 of the housing402 (face 420 a) and the smallest dimension Ds4 (face 420 b) (FIG. 11).The one or more faces 420 b may have the smallest area. The power supply420 may comprise a planar rectangular battery or a planar cylindricalbattery. In some embodiments, the power supply 420 is chargeable for atleast a 7-day use. It should be noted that in some embodiments, thefluid infusion device 400 may also include a buck boost converter toboost the voltage of the power supply 420 supplied to the control module422.

The control module 422 may be in communication with the power supply 420and drive system 110. As depicted in FIG. 18, the control module 422 maybe in communication with a charging coil 424 to supply power to thepower supply 420. The control module 422 may control the operation ofthe fluid infusion device 400 based on patient specific operatingparameters. In some embodiments, the control module 422 may control thesupply of power from the power supply 420 to the drive system 110 toactivate the drive system 110 to dispense fluid from the fluid reservoirsystem 116. Further detail regarding the control of the fluid infusiondevice 400 can be found in U.S. Pat. Nos. 6,485,465 and 7,621,893, therelevant content of which was previously incorporated herein byreference.

Briefly, the control module 422 may include at least one processor and acomputer readable storage device or media, which are mounted to aprinted circuit board 422 a. In some embodiments, the printed circuitboard 422 a is a rigid printed circuit board that enables communicationbetween the power supply 420, drive system 110, the charging coil 424,424′, the other components associated with the fluid infusion device 400and the control module 422. The processor can be any custom made orcommercially available processor, a central processing unit (CPU), anauxiliary processor among several processors associated with the controlmodule 422, a semiconductor based microprocessor (in the form of amicrochip or chip set), a macroprocessor, any combination thereof, orgenerally any device for executing instructions. The computer readablestorage device or media may include volatile and nonvolatile storage inread-only memory (ROM), random-access memory (RAM), and keep-alivememory (KAM), for example. KAM is a persistent or non-volatile memorythat may be used to store various operating variables while theprocessor is powered down. The computer-readable storage device or mediamay be implemented using any of a number of known memory devices such asPROMs (programmable read-only memory), EPROMs (electrically PROM),EEPROMs (electrically erasable PROM), flash memory, or any otherelectrical, magnetic, and/or optical memory devices capable of storingdata, some of which represent executable instructions, used by thecontrol module 422 in controlling components associated with the fluidinfusion device 400.

The instructions may include one or more separate programs, each ofwhich comprises an ordered listing of executable instructions forimplementing logical functions. The instructions, when executed by theprocessor, receive and process input signals, perform logic,calculations, methods and/or algorithms for controlling the componentsof the fluid infusion device 400, and generate signals to components ofthe fluid infusion device 400 to control the drive system 110 based onthe logic, calculations, methods, and/or algorithms Although only onecontrol module 422 is shown, embodiments of the fluid infusion device400 can include any number of control modules that communicate over anysuitable communication medium or a combination of communication mediumsand that cooperate to process signals received from the portableelectronic device, perform logic, calculations, methods, and/oralgorithms, and generate control signals to control features of thefluid infusion device 400. In various embodiments, one or moreinstructions of the control module 422, when executed by the processor,receive and process signals from the portable electronic deviceassociated with a user to generate one or more control signals to thepower supply 420 to supply power to the drive system 110, for example.

With reference to the example of FIG. 18, the charging coil 424comprises a plurality of concentric signal trace coils 424 a embedded intwo layers on a flexible printed circuit board 425. The flexible printedcircuit board 425 is electrically and physically coupled to the printedcircuit board 422 a to enable communication between the charging coil424 and the control module 422. In this example, the use of the flexibleprinted circuit board 425 allows the charging coil 424 to be containedwithin the housing 402 (FIG. 13) without taking up space on the printedcircuit board 422 a, and enables the charging coil 424 to be placedwithin the housing 402 wherever it is mechanically feasible. Thecharging coil 424 enables the ability for a user to wirelessly chargethe fluid infusion device 400 via inductive charging. In some examples,magnetic coupling between a wireless charging dongle 434 and the fluidinfusion device 400 is provided via a magnet positioned within thewireless charging dongle 434 of FIG. 20B, which is magneticallyattracted to a ferrous material that is placed inside the fluid infusiondevice 400. Alternatively, the flexible printed circuit board 425 mayinclude a coupler 428. In some examples, the coupler 428 is a diskcomposed of a ferrous material, which acts as a magnetic shield whileimproving magnetic coupling between the fluid infusion device 400 and aremote charging source, such as the wireless charging dongle 434 and/orcharging mat 432. It should be noted that the coupler 428 may have anydesired size and shape. In this example, the coupler 428 is coupled tothe backside of the flexible printed circuit board 425.

It should be noted, however, that various other configurations of thecharging coil 424 relative to the printed circuit board 422 a are alsocontemplated. For example, FIG. 19 depicts a charging coil 424′. Thecharging coil 424′ comprises a plurality of concentric signal tracecoils 424 a′ embedded on the printed circuit board 422 a. The tracecoils 424 a′ are electrically and physically coupled to the printedcircuit board 422 a to enable communication between the charging coil424′ and the control module 422. The charging coil 424′ also enables theability for a user to wirelessly charge the fluid infusion device 400.In some examples, the printed circuit board 422 a for use with thecharging coil 424′ may also include the coupler 428, which may becoupled to the backside of the printed circuit board 422 a.Alternatively, the charging coil 424 may be formed on a separate circuitboard, and communicatively coupled to the printed circuit board 422 a.

With reference to the example of FIG. 20A, an exemplary method forcharging the fluid infusion device 400 utilizing the charging coil 424or charging coil 424′ is shown. In this example, the fluid infusiondevice 400 is positioned upon a charging mat 432, and the charging mat432 cooperates with the charging coil 424, 424′ to charge the fluidinfusion device 400 wirelessly via induction. The charging mat 432 maycomprise any suitable charging mat capable of inductively charging thefluid infusion device 400, and may be connected to a power source via aUSB connection, for example. Generally, charging mat 432 may include aninduction coil, which cooperates with the charging coil 424, 424′ (thatacts as a receiver coil) to charge the fluid infusion device 400.

Alternatively, with reference to the example of FIG. 20B, anotherexemplary method for charging the fluid infusion device 400 utilizingthe charging coil 424 or charging coil 424′ is shown. In this example,the wireless charging dongle 434 is coupled to the fluid infusion device400, and the wireless charging dongle 434 cooperates with the chargingcoil 424, 424′ to charge the fluid infusion device 400 wirelessly viainduction. In one example, the wireless charging dongle 434 is coupledto the fluid infusion device 400 magnetically, via the magnet containedwithin the wireless charging dongle 434 and the coupler 428. Thewireless charging dongle 434 may comprise any suitable charging donglecapable of inductively charging the fluid infusion device 400, and maybe connected to a power source via a USB connection, for example. Thewireless charging dongle 434 may include an induction coil, whichcooperates with the charging coil 424, 424′ (that acts as a receivercoil) to charge the fluid infusion device 400. The use of the wirelesscharging dongle 434 allows the fluid infusion device 400 to be chargedeither while worn on the body or when carried in a pocket. The couplingof the wireless charging dongle 434 to the fluid infusion device 400 ispermissible through clothing, which allows the fluid infusion device 400to be charged without being taken off or disconnected from the user.Also, if the user forgets he/she is charging the fluid infusion device400 and walks away from the wireless charging dongle 434, the wirelesscharging dongle 434 harmlessly detaches from the fluid infusion device400. In this regard, the magnetic coupling of the wireless chargingdongle 434 and the fluid infusion device 400 enables the wirelesscharging dongle 434 to be attached to the user through clothing, whilealso enabling the inductive charging of the fluid infusion device 400.It should be noted in other implementations, the wireless chargingdongle 434 may not include a magnet for magnetically coupling to thefluid infusion device 400, and may be positioned onto or in proximity tothe fluid infusion device 400 to perform the inductive charging. Inother implementations, the fluid infusion device 400 may also send anotification to a remote portable device associated with the user basedon the alignment of the wireless charging dongle 434 relative to thefluid infusion device 400 to instruct the user to modify the alignmentto improve charging. It should be noted that the shape and configurationof the wireless charging dongle 434 in FIG. 20B is merely exemplary, asthe wireless charging dongle 434 may have any desired size or shape thatfacilitates the inductive charging of the fluid infusion device 400. Itshould be understood that the methods depicted in FIGS. 20A, 20B areshown independently, the charging coils 424, 424′ are capable ofwirelessly charging the fluid infusion device 400 using either one ofthe charging mat 432 or wireless charging dongle 434, and thus, thefluid infusion device 400 may be packaged for a consumer with thecharging mat 432, the wireless charging dongle 434 or both the chargingmat 432 and the wireless charging dongle 434, if desired.

Alternatively, with reference to FIG. 20C, the power supply 420 may alsobe rechargeable via USB charging. In the example of USB charging, thehousing 402 may define a micro-USB port to enable an electricalconnection between a USB cable 438 and a micro-USB receptacle 436electrically coupled to and in communication with the control module 422of the fluid infusion device 400 and a remote charging source. Thecontrol module 422 is in communication with the USB receptacle 436 tosupply power received to the power supply 420.

In certain instances, the control module 422 is in communication with anantenna 426. In some examples, the antenna 426 is an RF transceiver,which is electrically and physically coupled to the printed circuitboard 422 a of the control module 422. It should be noted, however, thatthe antenna 426 may comprise any suitable antenna 426 that enablesbi-directional communication between the fluid infusion device 400 andanother portable electronic device of the user. Thus, generally, theantenna 426 enables wireless communication between the fluid infusiondevice 400 and another device, including, but not limited to, aninfusion pump, continuous glucose monitor, infusion monitor unit,portable electronic device (tablet, smart phone, etc.) and/or anothermonitoring device. In some examples, the antenna 426 may include, but isnot limited to, a near-field communication (NFC) antenna, a radiofrequency (RF) communication antenna, a far-field communication antenna,a wireless communication system configured to communicate via a wirelesslocal area network (WLAN) using Institute of Electrical and ElectronicsEngineers (IEEE) 802.11 standards or by using cellular datacommunication, a BLUETOOTH antenna, etc. In certain embodiments, theantenna 426 of the fluid infusion device 400 may include more than onecommunication device, such as an NFC transceiver and a BLUETOOTH lowenergy (BLE) antenna.

In some examples, the fluid infusion device 400 includes an NFCtransceiver and a BLUETOOTH low energy (BLE) antenna. In the example,with reference to FIG. 21, the fluid infusion device 400 is capable ofcommunicating with one or more remote portable electronic devices,including, but not limited to, a portable electronic device such as asmartphone 440 and a continuous glucose monitor 442. It should be notedthat the smartphone 440 and the continuous glucose monitor 442 aremerely examples, as the fluid infusion device 400 may communicatewirelessly with any suitable user device, such as a computer, smartwatch, tablet, infusion monitor unit as discussed herein, etc. In someexamples, the fluid infusion device 400, the smartphone 440 and thecontinuous glucose monitor 442 are part of a mesh network, which enablescommunication between any two devices of the fluid infusion device 400,the smartphone 440 and the continuous glucose monitor 442. In some otherexamples, the fluid infusion device 400, the smartphone 440 and thecontinuous glucose monitor 442 are part of a star network. In suchexamples, the fluid infusion device 400 is the center of the starnetwork such that the continuous glucose monitor 442 and the smartphone440 never directly communicate. Rather, information from the continuousglucose monitor 442 must travel through the fluid infusion device 400 toreach the smartphone 440 and vice versa.

In the example of FIG. 21, the fluid infusion device 400 does notinclude a user interface, and the smartphone 440 is used to interfacewith the fluid infusion device 400. Thus, data associated with the fluidinfusion device 400 is displayed to the user via the smartphone 440, noton the fluid infusion device 400. In addition, the user inputs (e.g.user-controlled settings) are provided to the fluid infusion device 400via input on the smartphone 440. It should be noted that in someembodiments, the fluid infusion device 400 may have a reset button orone or several indicator light emitting diodes (LEDs) which shinethrough the housing of the fluid infusion device 400. The LEDs mayindicate various data such as data indicating that the fluid infusiondevice 400 is “on,” the fluid infusion device 400 is undergoing wirelesscharging, the fluid infusion device 400 is done with wireless charging,etc. It should be noted that while the smartphone 440 is shown andillustrated herein as comprising the portable electronic device, a smartwatch, tablet, computer, etc. may be used in addition to or instead ofthe smartphone 440 to communicate with the fluid infusion device 400.

As discussed previously, with reference back to FIG. 13, the drivesystem 110 cooperates with the fluid reservoir system 116 to dispensethe fluid from the fluid reservoir system 116. Generally, the drivesystem 110 is configured to be serially coupled to the removable fluidreservoir 160 such that a combined dimension of the drive system 110 andthe removable fluid reservoir 160 is less than or equal to the largestdimension DL4 of the housing 402 (FIG. 13). The drive system 110includes the motor 130, the gear box 132, the drive screw 134, the slide136 and the force sensor 138. The motor 130 receives power from thepower supply 420 as controlled by the control module 422. As discussed,the rotation of the drive screw 134 causes the linear translation of theslide 136. The slide 136 is also movable to a plurality of positionsbetween the first, retracted position and the second, fully extendedposition via the operation of the motor 130. The forward advancement ofthe slide 136 (i.e. the movement of the slide 136 toward the fluidreservoir system 116) causes the fluid reservoir system 116 to dispensefluid. The force sensor 138 is operatively associated with the drivesystem 110, and is in communication with the control module 422. Thefluid reservoir system 116 includes the fluid reservoir 160 and thesealing member 162. The fluid reservoir 160 is received within theopening 410 (FIG. 11) defined by the housing 402. The fluid reservoir160 is removable from the housing 402 to enable replacement as needed.The fluid reservoir 160 includes the body or barrel 164 and the stopper166. The barrel 164 has the first or distal barrel end 168 and thesecond or proximal barrel end 170. Fluid is retained within the barrel164 between the distal barrel end 168 and the proximal barrel end 170.The proximal barrel end 170 can have any desirable size and shapeconfigured to mate with at least a portion of an infusion set assembly300, as will be discussed in further detail herein. In some examples,the proximal barrel end 170 defines a passageway 172 through which thefluid flows out of the fluid reservoir 160. The passageway 172 is closedby the septum (not shown). The septum is pierceable by the infusion setassembly 300 to define a fluid flow path out of the fluid reservoir 160.

In some examples, with reference to FIG. 22A, the infusion set assembly300 includes the connector 302, the hollow instrument or needle 304 andthe tube 306. The connector 302 couples the needle 304 and the tube 306to the fluid reservoir 160, and locks into place once coupled to thefluid reservoir 160 to maintain the fluid flow path between the fluidreservoir 160 and an infusion unit 308, as shown in FIG. 22B. Theconnector 302 is a removable reservoir cap (or fitting) that is suitablysized and configured to accommodate replacement of the fluid reservoir160 (which are typically disposable) as needed. The needle 304 defines aflow path for the fluid out of the fluid reservoir 160, through theconnector 302 and into the tube 306.

In some examples, with reference to FIG. 22C, the first housing portion404 and the second housing portion 406 include opposing slots 444. Withreference to FIG. 22D, each slot 444 may define a pocket 444 a. Theopposing slots 444 are sized to receive corresponding tabs 446 definedon the connector 302, and the pocket 444 a cooperates with the tabs 446to secure the connector 302 to the fluid infusion device 400. The tabs446 are cantilevered, and are movable to lock into place in therespective pocket 444 a. The cooperation between the opposing slots 444and the tabs 446 enables the user to rotate the connector 302 onto thefluid reservoir 160 until the tab 446 expands into the pocket 444 a.Once the tab 446 is disposed in the pocket 444 a, the connector 302 iscoupled to the fluid infusion device 400 and the tube 306 facilitates afluidic connection between the fluid reservoir 160 and the infusion unit308.

As discussed, the fluid infusion device 400 may be carried by the user,in a pocket of the user's clothing, for example. Alternatively, withreference to the example of FIG. 23A, the fluid infusion device 400 maybe coupled or adhered to a body of the user. In this regard, thecoupling slot 414 (FIGS. 17A-17C) of the second housing portion 406 maybe used to couple the fluid infusion device 400 to a patch plate 450.The patch plate 450 in this example, is rigid, and is composed of apolymeric material, including, but not limited to acrylonitrilebutadiene styrene (ABS), nylon, an acrylonitrile butadiene styrenepolycarbonate blend, polyvinyl chloride, polytetrafluoroethylene (PTFE),polypropylene, polyether ether ketone (PEEK), polycarbonate or the like.The patch plate 450 may be molded, additively manufactured, etc. Thepatch plate 450 includes a top plate side 452 and an opposite secondplate side 454. The top plate side 452 defines a rail 456. The rail 456is shaped and configured to be received within the coupling slot 414.The coupling slot 414 may extend only over a portion of the secondhousing portion 406, or may extend over an entirety of the secondhousing portion 406. Generally, the fluid infusion device 400 may bemoved or slid over the patch plate 450 such that the rail 456 isreceived within the coupling slot 414 to couple the fluid infusiondevice 400 to the patch plate 450 as shown in FIG. 23B. The second plateside 454 includes a biocompatible adhesive 458 for coupling the patchplate 450 to an anatomy of the user. In some examples, the adhesive 458is provided on an adhesive patch, which is coupled to the second plateside 454 during manufacturing of the patch plate 450, via a double sidedpressure sensitive adhesive, for example. The adhesive 458 may comprisea hydrogel based, silicone-based, or acrylic-based adhesive, which iscapable of coupling the patch plate 450 to the anatomy. The adhesive 458may be covered with a liner (not shown) to protect the adhesive 458during shipping of the patch plate 450, for example.

With reference to the example of FIG. 24A, the fluid infusion device 400may be coupled or adhered to a body of the user with an alternativepatch plate 460. The coupling slot 414 (FIGS. 17A-17C) of the secondhousing portion 406 may be used to couple the fluid infusion device 400to the patch plate 460. The patch plate 460 in this example, isflexible, and is composed of a polymeric material, including, but notlimited to thermoplastic elastomers (TPE), thermoplastic polyurethane(TPU), silicone etc. In some examples, long edges of the patch plate 460are capable of being displaced by about 1.0 millimeter or more from aplane upon which the patch plate 460 rests to provide increased comfortto the user. The patch plate 460 may be molded, additively manufactured,etc. The patch plate 460 includes a top plate side 462 and an oppositesecond plate side 464. The top plate side 462 defines a rail 466. Therail 466 is shaped and configured to be received within the couplingslot 414. The coupling slot 414 may extend only over a portion of thesecond housing portion 406, or may extend over an entirety of the secondhousing portion 406. Generally, the fluid infusion device 400 may bemoved or slid over the patch plate 460 such that the rail 466 isreceived within the coupling slot 414 to couple the fluid infusiondevice 400 to the patch plate 460 as shown in FIG. 24B. The second plateside 464 includes a biocompatible adhesive 468 for coupling the patchplate 460 to an anatomy of the user. In some examples, the adhesive 468is provided on an adhesive patch, which is coupled to the second plateside 464 during manufacturing of the patch plate 460, via a double sidedpressure sensitive adhesive, for example. In other embodiments, theadhesive 468 may be formed on the second plate side 464, if desired. Theadhesive 468 may comprise a hydrogel based, silicone-based, oracrylic-based adhesive, which is capable of coupling the patch plate 460to the anatomy. The adhesive 468 may be covered with a liner (not shown)to protect the adhesive 468 during shipping of the patch plate 460, forexample.

It should be noted that while the fluid infusion device 400 is describedabove as being coupled to the patch plates 450, 460 via sliding alongthe rail 456, 466, which mates with the coupling slot 414, the fluidinfusion device 400 may be coupled to the patch plate 450, 460 byvarious other techniques. In some examples, the fluid infusion device400 may be coupled to the patch plate 450, 460 via magnetic coupling. Inthis regard, the patch plate 450, 460 may include a magnet, whichcouples with the coupler 428 of the fluid infusion device 400 to providea holding force that couples the fluid infusion device 400 to the patchplate 450, 460. In some examples, the patch plate 450, 460 may include asleeve, which extends outwardly from the patch plate 450, 460 anddefines a receptacle that is shaped to receive the fluid infusion device400. In these examples, the fluid infusion device 400 may be slid intothe sleeve and retained on the patch plate 450, 460 via friction. Insome examples, the patch plate 450, 460 may include one or moremechanical fasteners, such as plastic screws, which are used tomechanically couple the housing 402 of the fluid infusion device 400 tothe patch plate 450, 460. The mechanical fasteners, such as the plasticscrews, may engage with threaded bores defined within the second housingportion 406 of the housing 402, for example. It should be noted that anycombination of these methods may be employed to couple the fluidinfusion device 400 to the patch plate 450, 460.

Although the fluid infusion device 400 is shown in FIGS. 22A and 22B foruse with the infusion set assembly 300, which includes an elongated orlong tube 306, it should be noted that the fluid infusion device 400 incombination with the patch plate 450, 460 may be used with alternativedevices to enable a fluid flow path from the fluid reservoir 160 to ananatomy of a user. For example, with reference to FIG. 25, an infusionset assembly 300′ includes the connector 302, the hollow instrument orneedle 304 and a tube 306′. The connector 302 couples the needle 304 andthe tube 306′ to the fluid reservoir 160, and locks into place oncecoupled to the fluid reservoir 160 to maintain the fluid flow pathbetween the fluid reservoir 160 and the infusion unit 308. In thisexample, the tube 306′ has a length, which is different, and in thisexample, less than a length of the tube 306 (FIGS. 22A and 22B). In someexamples, the tube 306′ may have a length of about 3.0 millimeters (mm)to about 5 inches (in.), while the tube 306 (FIGS. 22A and 22B) may havea length of greater than 5 inches (in.) to 4 feet (ft.) The infusion setassembly 300′ in combination with the patch plate 450, 460 enables thefluid infusion device 400 to be used as a patch pump.

Although the fluid infusion device 400 is shown in FIGS. 22A, 22B and 25for use with the infusion set assembly 300, 300′, it should be notedthat the fluid infusion device 400 may be used with alternative devicesto enable a fluid flow path from the fluid reservoir 160 to an anatomyof a user. For example, with reference to FIG. 26A, a needle connector470 is shown. The needle connector 470 includes a cap 472 and a hollowinstrument or needle 474. The needle connector 470 may be composed of asuitable biocompatible material, including, but not limited to abiocompatible polymer, which may be molded, additively manufactured,etc. The cap 472 couples the needle 474 to the fluid reservoir 160, asshown in the example of FIG. 26B, and locks into place once coupled tothe fluid reservoir 160 to maintain the fluid flow path between thefluid reservoir 160 and the needle 474. The cap 472 is a removablereservoir cap (or fitting) that is suitably sized and configured toaccommodate replacement of the fluid reservoir 160 (which are typicallydisposable) as needed. The needle 474 defines a flow path for the fluidout of the fluid reservoir 160, through the cap 472. The needle 474includes opposed ends, one end of which is to pierce the septumassociated with the fluid reservoir 160, while the other exposed end isfor piercing a skin of the user to deliver the fluid into the anatomy ofthe user. Thus, in this example, the needle connector 470 enables thefluid infusion device 400 to be used as a pen to inject the fluiddirectly into the anatomy of the user. Alternatively, the user may usethe fluid infusion device 400, with the needle connector 470 coupled tothe fluid reservoir 160 to inject the fluid into an injection port 476coupled to the anatomy of the user, such as an i-Port Advance™commercially available from Medtronic MiniMed, Inc. of Northridge,Calif., USA. Thus, the needle connector 470 defines the fluid flow pathfrom the fluid reservoir 160 to an injection site, such as the anatomyof the user or the injection port 476.

It should be noted that in certain embodiments, the needle connector 470may include a magnet, and the fluid infusion device 400 may include amagnetic field sensor in communication with the control module 422. Insuch embodiments, the fluid infusion device 400 may determine, based ona detected magnetic field by the magnetic field sensor, that the needleconnector 470 is coupled to the fluid infusion device 400 prior todispensing the fluid. In addition, the magnetic field sensor may observea magnetic field generated by a magnet coupled to the infusion setassembly 300, such as the connector 302, to determine the type ofinfusion set assembly 300 coupled to the fluid infusion device 400. Forexample, the infusion set assembly 300, 300′ (or any of the infusion setassemblies discussed herein) may include the tube 306, 306′ that islonger or shorter than another infusion set assembly, and the controlmodule 422 may process the signals from the magnetic field sensor anddetermine which infusion set assembly (long tube 306, short tube 306′,etc.) is coupled to the fluid infusion device 400. For example, thecontrol module 422 of the fluid infusion device 400 is able to determineif a longer infusion set assembly or a smaller infusion set assembly isconnected based on the orientation of the magnet placed in each of therespective connectors 302 (i.e. the magnet in the connector 302 of thelonger infusion set assembly 300 may be oriented 90 degrees as comparedto the connector 302 for the shorter infusion set assembly 306′), whichis observed by the magnetic field sensor and processed by the controlmodule 422. In some examples, the control module 422 of the fluidinfusion device 400 is able to determine if the infusion set assembly300 or the needle connector 470 is connected based on the orientation ofthe magnet placed in each of the respective connectors (i.e. the magnetin the needle connector 470 may be oriented 90 degrees as compared tothe connector 302, for example, for the infusion set assembly 300),which is observed by the magnetic field sensor and processed by thecontrol module 422. Further, the control module 422 of the fluidinfusion device 400 is able to determine if a longer infusion setassembly 300, a smaller infusion set assembly 300′ or the needleconnector 470 is connected based on the orientation of a magnet placedin each of the respective connectors, which is offset by apre-determined amount (e.g. increments of 30 degrees) that is observedby the magnetic field sensor and processed by the control module 422.Further, the control module 422 may be able to distinguish betweeninfusion set assemblies of different lengths without a glucose sensor,and infusion set assemblies of different lengths that include a glucosesensor, based on an orientation of a magnet coupled to each of therespective infusion set assemblies and observed by the magnetic fieldsensor. The control module 422 may access a look-up table, for example,to determine the infusion set assembly based on the sensor signalsreceived by the magnetic field sensor.

Referring back to FIG. 13, in some examples, with the slide 136, thedrive screw 134, the gear box 132 and the motor 130 provided, the motor130 is coupled to the gear box 132 and the drive screw 134 is coupled tothe gear box 132. The slide 136 is positioned over the drive screw 134and the threads 134 a of the drive screw 134 threadably engage thethreads 142 a of the slide 136. With the second housing portion 406formed, the assembled drive system 110 is coupled to the second housingportion 406. The control module 422 is coupled to the power supply 420to be in communication with the power supply 420, and with the chargingcoil 424, 424′ and the antenna 426 coupled and in communication with thecontrol module 422, the control module 422 and the power supply 420 arecoupled to the second housing portion 406. The motor 130 is coupled tothe control module 422 to receive the one or more control signals todrive the motor 130. The force sensor 138 is positioned within thesecond housing portion 406 and electrically connected to the printedcircuit board 422 a to be in communication with the control module 422.The sealing members 162, 416 are coupled to the second housing portion406. With the first housing portion 404 formed, the first housingportion 404 is coupled to the second housing portion 406, via welding,for example.

With the fluid infusion device 400 assembled, the fluid infusion device400 may be packaged and shipped to an end user. Once received, the enduser may remove the packaging and with reference to FIGS. 22A and 22B,the user may couple the fluid reservoir 160 to the housing 402 bypositioning the fluid reservoir 160 within the opening 410 (FIG. 12)defined in the housing 402. In some embodiments, the fluid reservoir 160is prefilled with fluid (for example, insulin) such that the stopper 166is positioned at the distal barrel end 168 (FIG. 13). In some examples,the connector 302 is coupled to the fluid reservoir 160 prior toinsertion of the fluid reservoir 160 into the housing 402 for ease ofhandling by the user. With the infusion set assembly 300 fixedly coupledor secured to the housing 402, the needle 304 pierces the septum,thereby defining a fluid flow path for the fluid out of the fluidreservoir 160. With the infusion set assembly 300 coupled to the fluidreservoir 160 and the infusion unit 308 coupled to the anatomy of theuser, one or more control signals from the control module 422 can drivethe motor 130, thereby rotating the drive screw 134, which results inthe linear translation of the slide 136. The advancement of the slide136 into the fluid reservoir 160 moves the stopper 166, causing thefluid to flow from the fluid reservoir 160 through the fluid flow pathdefined by the infusion set assembly 300.

Alternatively, in the case of the needle connector 470, with the needleconnector 470 coupled to the fluid reservoir 160 such that the needle474 pierces the septum to define a fluid flow path from the fluidreservoir 160, the exposed end of the needle 474 is inserted into theinjection site. One or more control signals from the control module 422drives the motor 130, thereby rotating the drive screw 134, whichresults in the linear translation of the slide 136. The advancement ofthe slide 136 into the fluid reservoir 160 moves the stopper 166,causing the fluid to flow from the fluid reservoir 160 through the fluidflow path defined by the needle 474 and into the injection site.

With reference to FIGS. 23A-24B, it should be noted that the end usermay also take one of the patch plates 450, 460 and may slidably couplethe coupling slot 414 of fluid infusion device 400 (FIG. 17A) to therespective rail 456, 466 of the patch plate 450, 460. The user mayremove the backing from the adhesive 458, 468 of the respective patchplate 450, 460, and couple the adhesive 458, 468, and thus, the fluidinfusion device 400, to the anatomy of the user.

It should be noted that configurations of the fluid infusion device 400may vary from implementation to implementation. For example, withreference to FIG. 27, a portable fluid infusion device 500 is shown. Asthe fluid infusion device 500 includes the same or similar components asthe fluid infusion device 400 discussed with regard to FIGS. 11-26B, thesame reference numerals will be used to denote the same or similarcomponents. FIG. 27 is a perspective view of the fluid infusion device500, and FIG. 28 is an exploded view. The fluid infusion device 500 maybe used with the infusion set assembly 300 or other devices, such as theinfusion set assembly 300′ or the needle connector 470. In the examplesof FIGS. 27 and 28, the fluid infusion device 500 is shown with theinfusion set assembly 300.

In these examples, the fluid infusion device 500 includes a housing 502.Generally, the housing 502 has a small form factor for portability andis about 15 millimeters (mm) to about 25 millimeters (mm) thick, about20 millimeters (mm) to about 30 millimeters (mm) wide and is about 75millimeters (mm) to about 85 millimeters (mm) long. In some examples,the housing 502 includes a first housing portion 504 and a secondhousing portion 506, which are coupled together to form the housing 502.The first housing portion 504 and the second housing portion 506 mayeach be composed of a polymeric material, including, but not limited topolycarbonate, and may be molded, additive manufactured, etc. Generally,with reference to FIG. 28, the first housing portion 504 and the secondhousing portion 506 cooperate to enclose the power supply 420, thecontroller or control module 422, the drive system 110 and the fluidreservoir system 116. In this example, the fluid infusion device 500 isdevoid of a user interface.

In some examples, the first housing portion 504 is slid over the secondhousing portion 506, and the first housing portion 504 and the secondhousing portion 506 are coupled together via welding, including, but notlimited to laser welding, ultrasonic welding, radiofrequency welding,etc. In certain embodiments, the first housing portion 504 and thesecond housing portion 506 may each have alignment features, whichassist in coupling the first housing portion 504 to the second housingportion 506. In the examples of FIGS. 27 and 28, the first housingportion 504 is substantially C-shaped, and is sized to substantiallysurround the second housing portion 506. The second housing portion 506includes a plurality of chambers 510. In some examples, with referenceto FIG. 29, the second housing portion 506 includes a connector chamber510 a, a reservoir chamber 510 b, a drive chamber 510 c and anelectronics chamber 510 d. The chambers 510 a-510 d cooperate to containthe respective components for ease of assembly of the fluid infusiondevice 500. The connector chamber 510 a is in communication with thereservoir chamber 510 b. The connector chamber 510 a receives theconnector 302 or needle connector 470 (FIG. 26A), and defines an opening512 into the second housing portion 506 that receives the fluidreservoir 160 and the connector 302. The reservoir chamber 510 breceives the fluid reservoir 160. The drive chamber 510 c is incommunication with the electronics chamber 510 d. The drive chamber 510c receives the drive system 110, and the electronics chamber 510 dreceives the control module 422 and the power supply 420.

With reference to the example of FIG. 28, with the slide 136, the drivescrew 134, the gear box 132 and the motor 130 provided, the motor 130 iscoupled to the gear box 132 and the drive screw 134 is coupled to thegear box 132. The slide 136 is positioned over the drive screw 134 andthe threads 134 a of the drive screw 134 threadably engage the threads142 a of the slide 136. With the second housing portion 506 formed, theassembled drive system 110 is coupled to the drive chamber 510 c of thesecond housing portion 506. The control module 422 is coupled to thepower supply 420 to be in communication with the power supply 420, andwith the charging coil 424, 424′ and the antenna 426 coupled and incommunication with the control module 422, the control module 422 andthe power supply 420 are coupled to the electronics chamber 510 d of thesecond housing portion 506. The motor 130 is coupled to the controlmodule 422 to receive the one or more control signals to drive the motor130. The force sensor 138 is positioned within the drive chamber 510 cof the second housing portion 506 and electrically connected to theprinted circuit board 422 a to be in communication with the controlmodule 422. With the first housing portion 504 formed, the first housingportion 504 is coupled to the second housing portion 506.

With the fluid infusion device 500 assembled, the fluid infusion device500 may be packaged and shipped to an end user. Once received, the enduser may remove the packaging and the user may couple the fluidreservoir 160 to the housing 502 by positioning the fluid reservoir 160within the reservoir chamber 510 b defined in the housing 502. In someembodiments, the fluid reservoir 160 is prefilled with fluid (forexample, insulin) such that the stopper 166 is positioned at the distalbarrel end 168. In some examples, the connector 302 is coupled to thefluid reservoir 160 prior to insertion of the fluid reservoir 160 intothe housing 502 for ease of handling by the user. With the infusion setassembly 300 fixedly coupled or secured to the connector chamber 510 aof the housing 502, the needle 304 pierces the septum, thereby defininga fluid flow path for the fluid out of the fluid reservoir 160. With theinfusion set assembly 300 coupled to the fluid reservoir 160 and theinfusion unit 308 coupled to the anatomy of the user, one or morecontrol signals from the control module 422 can drive the motor 130,thereby rotating the drive screw 134, which results in the lineartranslation of the slide 136. The advancement of the slide 136 into thefluid reservoir 160 moves the stopper 166, causing the fluid to flowfrom the fluid reservoir 160 through the fluid flow path defined by theinfusion set assembly 300.

Alternatively, in the case of the needle connector 470, with the needleconnector 470 positioned within the connector chamber 510 a coupled tothe fluid reservoir 160 such that the needle 474 pierces the septum todefine a fluid flow path from the fluid reservoir 160, the exposed endof the needle 474 is inserted into the injection site. One or morecontrol signals from the control module 422 drives the motor 130,thereby rotating the drive screw 134, which results in the lineartranslation of the slide 136. The advancement of the slide 136 into thefluid reservoir 160 moves the stopper 166, causing the fluid to flowfrom the fluid reservoir 160 through the fluid flow path defined by theneedle 474 and into the injection site.

It should be noted that the fluid infusion device 500 may include thecoupling slot 414 defined in the second housing portion 506, forexample, to couple the fluid infusion device 500 to the patch plates450, 460. In this example, the fluid infusion device 500 may be coupledto the patch plates 450, 460 via sliding along the rail 456, 466 thatmates with the coupling slot 414. It should be noted that the fluidinfusion device 500 may be coupled to the patch plate 450, 460 byvarious other techniques. In some examples, the fluid infusion device500 may be coupled to the patch plate 450, 460 via magnetic coupling;the patch plate 450, 460 may include a sleeve, which extends outwardlyfrom the patch plate 450, 460 and defines a receptacle that is shaped toreceive the fluid infusion device 500; and/or the patch plate 450, 460may include one or more mechanical fasteners, such as plastic screws,which are used to mechanically couple the housing 502 of the fluidinfusion device 500 to the patch plate 450, 460 as discussed with regardto the fluid infusion device 400. It should be noted that anycombination of these methods may be employed to couple the fluidinfusion device 500 to the patch plate 450, 460.

It should be noted that in some embodiments, the fluid infusion device400 may be configured differently. For example, with reference to FIG.30, a portable fluid infusion device 600 is shown. As the fluid infusiondevice 600 includes the same or similar components as the fluid infusiondevice 400 discussed with regard to FIGS. 11-26B, the same referencenumerals will be used to denote the same or similar components. FIG. 30is a perspective view of the fluid infusion device 500, FIG. 31 is anend view and FIG. 32 is an exploded view. The fluid infusion device 600may be used with the infusion set assembly 300 or other devices, such asthe infusion set assembly 300′ or the needle connector 470.

In the examples of FIGS. 30-32, the fluid infusion device 600 includes ahousing 602. Generally, the housing 602 has a small form factor forportability and is about 15 millimeters (mm) to about 25 millimeters(mm) thick, about 33 millimeters (mm) to about 42 millimeters (mm) wideand is about 79 millimeters (mm) to about 89 millimeters (mm) long. Insome examples, the housing 602 includes a first housing portion 604 anda second housing portion 606, which are coupled together to form thehousing 602. The first housing portion 604 and the second housingportion 606 may each be composed of a polymeric material, including, butnot limited to polycarbonate, and may be molded, additive manufactured,etc. Generally, with reference to the example of FIG. 32, the firsthousing portion 604 and the second housing portion 606 cooperate toenclose a power supply 620, the power supply 420, the controller orcontrol module 422, the drive system 110 and the fluid reservoir system116. In this example, the fluid infusion device 600 is devoid of a userinterface.

In this example, the control module 422 is retained within the housing602 with the power supply 420 between the fluid reservoir system 116 andthe power supply 620. It should be noted that in some other embodiments,the control module 422 may be positioned and retained within analternative location within the housing 602. For example, with referenceto FIGS. 33 and 34, the control module 422 is coupled between the fluidreservoir system 116 and a side 602 b of the housing 602. In thisconfiguration, the housing 602 is about 15 millimeters (mm) to about 25millimeters (mm) thick, about 35 millimeters (mm) to about 45millimeters (mm) wide and is about 79 millimeters (mm) to about 89millimeters (mm) long.

Referring back to the example of FIGS. 30 and 31, the first housingportion 604 and the second housing portion 606 are coupled together in amanner that forms a seal at an interface 608 between the first housingportion 604 and the second housing portion 606. In these examples, thefirst housing portion 604 and the second housing portion 406 are coupledtogether via welding, including, but not limited to laser welding,ultrasonic welding, radiofrequency welding, etc.

The housing 602, when assembled, includes opposed sides 602 a, 602 b,and opposed ends 602 c, 602 d. Generally, the end 602 c defines anopening 610 to receive the fluid reservoir 160 and an opening 612 toreceive the power supply 620. Generally, the power supply 620, thecontrol module 422 and the drive system 110 are accommodated in a pumpchamber 612 a defined by the housing 602, and the fluid reservoir system116 is accommodated in a reservoir chamber 612 b defined by the housing602. The opposed sides 602 a, 602 b and the opposed ends 602 c, 602 d ofthe housing 602 define a plurality of faces of the housing 602, and inthis example, the faces 602 c, 602 d have the smallest area (compared tothe faces or sides 602 a, 602 b), and the opening 610, 612 are locatedon the face or end 602 c that has the smallest area.

The power supply 620 is any suitable device for supplying the fluidinfusion device 600 with power, including, but not limited to, abattery. In some examples, with reference to FIG. 32, the power supply620 is a disposable battery, which is received within a battery sleeve622 associated with the housing 602. In this example, the battery is aAAA battery, however, other disposable battery sizes may be employed.For example, with reference to FIGS. 35 and 36, the fluid infusiondevice 600 is shown with an AA battery as a power supply 620′. In thisconfiguration, the housing 602 is about 15 millimeters (mm) to about 25millimeters (mm) thick, about 35 millimeters (mm) to about 45millimeters (mm) wide and is about 79 millimeters (mm) to about 89millimeters (mm) long to accommodate the larger power supply. The powersupply 420 is a rechargeable battery, which is fixed within the housing602 and electrically coupled to the control module 422. Generally, thepower supply 420 is rechargeable via wireless charging, etc., asdiscussed. The power supply 420 is chargeable for at least a 7 day use,and in some examples, provides power and/or notifications when the powersupply 620 is at low power or needs replacement. It should be noted thatthe fluid infusion device 600 need not include the rechargeable powersupply 420, if desired.

The housing 602 may include a battery cap (not shown) to enclose thepower supply 620, 620′ when the battery is positioned within the housing602. The battery sleeve 622 is cylindrical, and receives the powersupply 620, 620′. The battery sleeve 622 is coupled or disposed withinthe housing 602.

The fluid infusion device 600 may be carried by the user, in a pocket ofthe user's clothing, for example. Alternatively, with reference to FIG.37A, the fluid infusion device 600 may be coupled or adhered to a bodyof the user. In this regard, the second housing portion 606 may alsoinclude the coupling slot 414 (FIGS. 17A-17C), which may be used tocouple the fluid infusion device 600 to the patch plate 450. The rail456 is shaped and configured to be received within the coupling slot 414of the second housing portion 606. Generally, the fluid infusion device600 may be moved or slid over the patch plate 450 such that the rail 456is received within the coupling slot 414 to couple the fluid infusiondevice 600 to the patch plate 450 as shown in FIG. 37B. The second plateside 454 includes the biocompatible adhesive 458 for coupling the patchplate 450 to an anatomy of the user. The adhesive 458 may be coveredwith a liner (not shown) to protect the adhesive 458 during shipping ofthe patch plate 450, for example.

With reference to FIG. 38A, the fluid infusion device 600 may be coupledor adhered to a body of the user with the patch plate 460. The couplingslot 414 (FIGS. 17A-17C) of the second housing portion 606 may be usedto couple the fluid infusion device 600 to the patch plate 460. The rail466 is shaped and configured to be received within the coupling slot414. Generally, the fluid infusion device 600 may be moved or slid overthe patch plate 460 such that the rail 466 is received within thecoupling slot 414 to couple the fluid infusion device 600 to the patchplate 460 as shown in FIG. 38B. The second plate side 464 includes thebiocompatible adhesive 468, which may be provided on an adhesive patchcoupled to the second plate side 464, for coupling the patch plate 460to an anatomy of the user. The adhesive 468 may be covered with a liner(not shown) to protect the adhesive 468 during shipping of the patchplate 460, for example.

It should be noted that while the fluid infusion device 600 is describedas being coupled to the patch plates 450, 460 via sliding along the rail456, 466, which mates with the coupling slot 414, the fluid infusiondevice 600 may be coupled to the patch plate 450, 460 by various othertechniques, as discussed with regard to the fluid infusion device 400 ofFIGS. 11-26B. For example, the fluid infusion device 600 may be coupledto the patch plate 450, 460 via magnetic coupling. In some examples, thepatch plate 450, 460 may include a sleeve, which extends outwardly fromthe patch plate 450, 460 and defines a receptacle that receives thefluid infusion device 600. In some examples, the patch plate 450, 460may include one or more mechanical fasteners, such as plastic screws,which are used to mechanically couple the fluid infusion device 600 tothe patch plate 450, 460.

Referring back to the example of FIG. 32, with the slide 136, the drivescrew 134, the gear box 132 and the motor 130 provided, the motor 130 iscoupled to the gear box 132 and the drive screw 134 is coupled to thegear box 132. The slide 136 is positioned over the drive screw 134 andthe threads 134 a of the drive screw 134 threadably engage the threads142 a of the slide 136. With the second housing portion 606 formed, theassembled drive system 110 is coupled to the second housing portion 606.The control module 422 is coupled to the power supply 420 to be incommunication with the power supply 420, and with the charging coil 424,424′ and the antenna 426 coupled and in communication with the controlmodule 422, the control module 422 and the power supply 420 are coupledto the second housing portion 606. The motor 130 is coupled to thecontrol module 422 to receive the one or more control signals to drivethe motor 130. The force sensor 138 is positioned within the secondhousing portion 606 and electrically connected to the printed circuitboard 422 a to be in communication with the control module 422. With thefirst housing portion 604 formed, the first housing portion 604 iscoupled to the second housing portion 606, via welding, for example.

With the fluid infusion device 600 assembled, the fluid infusion device600 may be packaged and shipped to an end user. Once received, the enduser may remove the packaging and the user may couple the fluidreservoir 160 to the housing 602 by positioning the fluid reservoir 160through the opening 610 defined in the housing 602. In some embodiments,the fluid reservoir 160 is prefilled with fluid (for example, insulin)such that the stopper 166 is positioned at the distal barrel end 168(FIG. 32). In some examples, the connector 302 is coupled to the fluidreservoir 160 prior to insertion of the fluid reservoir 160 into thehousing 602 for ease of handling by the user. The power supply 620, 620′may be inserted into the opening 612 and enclosed with a battery cap,for example. With the infusion set assembly 300 fixedly coupled orsecured to the housing 602, the needle 304 pierces the septum, therebydefining a fluid flow path for the fluid out of the fluid reservoir 160.With the infusion set assembly 300 coupled to the fluid reservoir 160and the infusion unit 308 coupled to the anatomy of the user, one ormore control signals from the control module 422 can drive the motor130, thereby rotating the drive screw 134, which results in the lineartranslation of the slide 136. The advancement of the slide 136 into thefluid reservoir 160 moves the stopper 166, causing the fluid to flowfrom the fluid reservoir 160 through the fluid flow path defined by theinfusion set assembly 300.

Alternatively, in the case of the needle connector 470, with the needleconnector 470 positioned within the connector chamber 510 a coupled tothe fluid reservoir 160 such that the needle 474 pierces the septum todefine a fluid flow path from the fluid reservoir 160, the exposed endof the needle 474 is inserted into the injection site. One or morecontrol signals from the control module 422 drives the motor 130,thereby rotating the drive screw 134, which results in the lineartranslation of the slide 136. The advancement of the slide 136 into thefluid reservoir 160 moves the stopper 166, causing the fluid to flowfrom the fluid reservoir 160 through the fluid flow path defined by theneedle 474 and into the injection site.

With reference to FIGS. 37A-38B, it should be noted that the end usermay also take one of the patch plates 450, 460 and may slidably couplethe coupling slot 414 of fluid infusion device 600 to the respectiverail 456, 466 of the patch plate 450, 460. The user may remove thebacking from the adhesive 458, 468 of the respective patch plate 450,460, and couple the adhesive 458, 468, and thus, the fluid infusiondevice 600, to the anatomy of the user.

While the fluid infusion devices 100, 400, 500, 600 are described hereinas using the infusion set assembly 300 to dispense a fluid to a user, itshould be noted that the infusion set assembly 300 may exhibit a varietyof different configurations. Further, as used herein, an infusion setassembly and a fluid infusion device comprise a fluid infusion system.For example, with reference to FIG. 39, an infusion set assembly 700 isshown coupled to a fluid infusion device 800. Insofar as the infusionset assembly 700 includes the same or similar components as the infusionset assembly 300 discussed with regard to FIGS. 1-38B and insofar as thefluid infusion device 800 includes the same or similar components as thefluid infusion device 400 discussed with regard to FIGS. 11-38B, thesame reference numerals may be used to denote the same or similarcomponents.

In the example of FIG. 39, the infusion set assembly 700 includes aconnector 702, the hollow instrument or needle 304 and a tube 706. Theconnector 702 couples with the fluid infusion device 800, and locks intoplace once coupled to maintain the fluid flow path between the fluidreservoir 160 and an infusion monitor unit 708 via the needle 304 andthe tube 706. In this example, as will be discussed, the infusionmonitor unit 708 is configured to both dispense a fluid, such asinsulin, into the anatomy of the user, and to also monitor, observe ormeasure a physiological characteristic, such as a blood glucose level ora glucose level, associated with the user.

The tube 706 includes a first or proximalmost end 707 and an oppositesecond end 706 b. The proximalmost end 707 is coupled to the infusionmonitor unit 708, while the second end 706 b is coupled to the connector702. In this example, the proximalmost end 707 of the tube 706 isinserted into the anatomy to provide the fluid flow path from the fluidreservoir 160 into the anatomy of the user. In some examples, withreference to FIG. 40, a cross-sectional view of the tube 706 is shown.The tube 706 includes a plurality of conduits 709. In this example, thetube 706 includes a fluid delivery conduit 709 a, a reference electrodeconduit 709 b, a counter electrode conduit 709 c and a working electrodeconduit 709 d. The fluid delivery conduit 709 a receives the fluid fromthe fluid reservoir 160 and directs the fluid from the fluid reservoir160 through the tube 706. In some examples, with reference to FIG. 41,the fluid delivery conduit 709 a terminates at a terminal end 707 a ofthe tube 706, such that a fluid outlet is defined at the terminal end707 a. With reference to FIG. 40, the reference electrode conduit 709 baccommodates a reference electrode 740 associated with the infusionmonitor unit 708, and directs the reference electrode 740 through thetube 706 to the connector 702. The counter electrode conduit 709 caccommodates a counter electrode 742 associated with the infusionmonitor unit 708, and directs the counter electrode 742 through the tube706 to the connector 702. The working electrode conduit 709 daccommodates a working electrode 744 associated with the infusionmonitor unit 708, and directs the working electrode 744 through the tube706 to the connector 702. As described in greater detail below, aplurality of electrodes (e.g., a reference electrode, a counterelectrode, and a working electrode) can work together to determine aphysiological characteristic (e.g., a glucose level) of a user. Such aplurality of electrodes may be collectively referred to herein as aphysiological characteristic sensor (e.g., a glucose sensor).

With reference to FIG. 41, the infusion monitor unit 708 is shown ingreater detail. The infusion monitor unit 708 includes a housing 710, acoupling member or adhesive patch 712 and a physiological characteristicsensor 716. The housing 710 may be composed of a biocompatible material,including, but not limited to a polymeric material, such asacrylonitrile butadiene styrene (ABS), nylon, an acrylonitrile butadienestyrene polycarbonate blend, polyvinyl chloride, polytetrafluoroethylene(PTFE), polysulfone, polypropylene, polyether ether ketone (PEEK),polycarbonate, polyurethane, silicone, polyethylene terephthalateglycol-modified (PETG) or the like. The housing 710 may be formedthrough molding, additively manufacturing, etc. The housing 710comprises a tube connector 720 and a mount 722. The tube connector 720is coupled to the tube 706 and to the mount 722. The tube connector 720can have any desired shape and configuration to receive the tube 706 inthe infusion monitor unit 708. In the example of FIG. 41, the tubeconnector 720 is annular and comprises a central bore 724. The centralbore 724 defines a passageway 724 a, which enables the tube 706 to passthrough the tube connector 720 and into a corresponding passageway 725defined in the mount 722. In this example, the passageways 724 a, 725enable the tube 706 to pass through the tube connector 720 and the mount722 so that the proximalmost end 707 of the tube 706 may be insertedinto the anatomy. The tube 706 can be coupled to the tube connector 720through any suitable technique, including, but not limited to,press-fit, adhesives, welding, etc.

In some examples, the mount 722 is substantially hemispherical, andincludes a first, top mount surface 726 and a second, bottom mountsurface 728 opposite the top mount surface 726. Together, the top mountsurface 726 and the bottom mount surface 728 enclose a chamber 730. Inthe example of FIG. 41, the top mount surface 726 is hemispherical andis coupled to the tube connector 720. The top mount surface 726 definesa coupling bore 726 a, which is coupled to the tube connector 720 toreceive the tube 706. The top mount surface 726 also defines aninsertion bore 726 b, which is sized to enable an insertion instrument,such as a needle, to be received through the mount 722 to facilitateinsertion of the proximalmost end 707 of the tube 706 into the anatomy.The insertion bore 726 b is generally sealed with a septum to inhibitfluid flow into and out of the infusion monitor unit 708. The bottommount surface 728 is coupled to the top mount surface 726 and to theadhesive patch 712. The bottom mount surface 728 defines a bore 728 a,through which the tube 706 passes through for insertion into theanatomy. The chamber 730 defines the passageway 725. The passageway 725receives the tube 706. In this example, the passageway 725 issubstantially L-shaped, such that the proximalmost end 707 of the tube706 extends along an axis that is substantially perpendicular to aremainder of the tube 706.

The adhesive patch 712 is coupled to the bottom mount surface 728 andaffixes the infusion monitor unit 708 to an anatomy, such as the skin ofthe user. The adhesive patch 712 may be covered and protected by aliner. The adhesive patch 712 may be composed of a flexible andbreathable material (e.g., a cloth and/or a bandage-like material) withone or more adhesive layers. For example, suitable materials couldinclude polyurethane, polyethylene, polyester, polypropylene,polytetrafluoroethylene (PTFE), or other polymers, to which one or moreadhesive layers are applied. Thus, the infusion monitor unit 708includes the housing 710 that is configured to be adhesively coupled toan anatomy of a user.

In this example, the physiological characteristic sensor 716 isintegrated with the tube 706 such that the tube 706 both delivers thefluid from the fluid reservoir 160 and also measures a physiologicalcharacteristic (e.g., a glucose level) within the anatomy of the user.It should be noted that the physiological characteristic sensor 716 isnot limited to a glucose sensor, but rather, various other physiologicalcharacteristic sensors may be employed. In some embodiments, thephysiological characteristic sensor 716 is an electrochemical sensorthat includes the glucose oxidase enzyme, as is well understood by thosefamiliar with glucose sensor technology. The glucose oxidase enzymeenables the physiological characteristic sensor 716 to monitor glucoselevels in a diabetic patient or user by effecting a reaction of glucoseand oxygen. Again, although certain embodiments pertain to glucosesensors, the technology described here can be adapted for use with anyone of the wide variety of sensors known in the art. In this example,the physiological characteristic sensor 716 is positionable insubcutaneous tissue of the user by the same insertion instrument thatinserts the proximalmost end 707 of the tube into the anatomy to measurethe glucose oxidase enzyme.

In some examples, the physiological characteristic sensor 716 includesthe reference electrode 740, the counter electrode 742 and the workingelectrode 744. The working electrode 744 may be coated with the glucoseoxidase enzyme. The reference electrode 740 maintains a constant voltageto support the reaction at working electrode 744. The counter electrode742 supplies current to maintain the set potential on the workingelectrode 744. The electrodes 740, 742, 744 may each be composed of asuitable biocompatible metal or metal alloy, such as copper, platinum,platinum-iridium, silver, gold, etc., and may be extruded. When glucoseand oxygen diffuse to the glucose oxidase layer, hydrogen peroxide isformed. Hydrogen peroxide present at the working electrode 744metallization layer breaks down and generates electrons when a voltageis applied to the working electrode 744. These electrons generates anelectrical signal, which is transmitted by the working electrode 744 andcommunicated to the control module 822 of the fluid infusion device 800,as will be discussed further herein.

As mentioned above, the physiological characteristic sensor 716 can beintegrated with the tube 706. However, sensor and tube configurationsmay vary from implementation to implementation. For example, withreference to FIG. 42, a physiological characteristic sensor (e.g.glucose sensor) 1000 is shown integrated with a tube 1002. Insofar asthe physiological characteristic sensor 1000 and the tube 1002 includesthe same or similar components as the physiological characteristicsensor 716 and the tube 706 discussed with regard to FIGS. 39-41, thesame reference numerals will be used to denote the same or similarcomponents.

The tube 1002 may facilitate a fluidic connection between connector,like the connector 702, and the infusion monitor unit 708, and aproximalmost end 1002 a of the tube 1002 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1002. The tube 1002 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane, and may be extruded, molded, cast,additively manufactured, etc. In some examples, the tube 1002 includes aplurality of conduits 1006 and a plurality of windows 1008. Withreference to FIG. 43, the plurality of conduits 1006 of the tube 1002includes a fluid delivery conduit 1006 a, a reference electrode conduit1006 b, a counter electrode conduit 1006 c and a working electrodeconduit 1006 d. The fluid delivery conduit 1006 a receives the fluidfrom the fluid reservoir 160 and directs the fluid from the fluidreservoir 160 through the tube 1002. In some examples, with referenceback to FIG. 42, the fluid delivery conduit 1006 a terminates at aterminal end 1002 b of the tube 1002, such that the terminal end 1002 bcomprises a fluid outlet 1010.

The reference electrode conduit 1006 b accommodates the referenceelectrode 740 associated with the physiological characteristic sensor1000, and directs the reference electrode 740 through the tube 1002 to aconnector, such as the connector 702 of FIG. 39. The counter electrodeconduit 1006 c accommodates the counter electrode 742 associated withthe physiological characteristic sensor 1000, and directs the counterelectrode 742 through the tube 1002 to the connector, such as theconnector 702 of FIG. 39. The working electrode conduit 1006 daccommodates the working electrode 744 associated with the physiologicalcharacteristic sensor 1000, and directs the working electrode 744through the tube 1002 to the connector, such as the connector 702 ofFIG. 39.

The plurality of windows 1008 of the tube 1002 includes a referenceelectrode window 1008 b, a counter electrode window 1008 c and a workingelectrode window 1008 d. The reference electrode window 1008 b isdefined through an outer surface 1002 c of the tube 1002, and exposesthe reference electrode 740 to interstitial fluid of the user when theproximalmost end 1002 a of the tube 1002 is inserted into the anatomy.Generally, each of the windows 1008 b-1008 d is defined through theouter surface 1002 c such that the respective electrode 740, 742, 744 issufficiently exposed to the interstitial fluid. The counter electrodewindow 1008 c exposes the counter electrode 742 to interstitial fluid ofthe user when the proximalmost end 1002 a of the tube 1002 is insertedinto the anatomy. The working electrode window 1008 d exposes theworking electrode 744 to interstitial fluid of the user when theproximalmost end 1002 a of the tube 1002 is inserted into the anatomy.

In some examples, each of the windows 1008 b-1008 d may be definedthrough the outer surface 1002 c of the tube 1002 for a differentrespective length Lb-Ld. In the example of FIG. 42, the length Lcassociated with the window 1008 c is different and greater than thelength Lb associated with the window 1008 b and the length Ld associatedwith the window 1008 d. The length Lb is different and greater than thelength Ld, and the length Lb is different and less than the length Lc.The length Ld is different and less than the length Lb and the lengthLc. In this example, the length Lc is greater than the length Lb and thelength Ld to expose more of a surface of the counter electrode 742,which may improve the operation of the physiological characteristicsensor 1000.

In this example, the physiological characteristic sensor 1000 includesthe reference electrode 740, the counter electrode 742 and the workingelectrode 744. The chemical reaction between the glucose and the oxygenat the working electrode 744 generates an electrical signal, which istransmitted by the working electrode 744 and communicated to the controlmodule 822 of the fluid infusion device 800, as will be discussedfurther herein.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 45, thephysiological characteristic sensor 1000 is shown integrated with a tube1102. Insofar as the physiological characteristic sensor 1000 and thetube 1102 includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41 and the physiological characteristic sensor 1000 and thetube 1002 discussed with regard to FIGS. 42-44, the same referencenumerals will be used to denote the same or similar components.

The tube 1102 may facilitate a fluidic connection between a connector,like the connector 702, and the infusion monitor unit 708, and aproximalmost end 1102 a of the tube 1102 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1102. The tube 1102 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc. In some examples, the tube 1102 includes aplurality of conduits 1106 and the plurality of windows 1008.

With reference to FIG. 46, the plurality of conduits 1106 of the tube1102 includes a fluid delivery conduit 1106 a, the reference electrodeconduit 1006 b, the counter electrode conduit 1006 c and the workingelectrode conduit 1006 d. The fluid delivery conduit 1106 a receives thefluid from the fluid reservoir 160 and directs the fluid from the fluidreservoir 160 through the tube 1102. In some embodiments, the tube 1102may comprise one or more fluid outlets. For example, in FIG. 47, thefluid delivery conduit 1106 a of the tube 1102 includes a plurality offluid outlets 1110 defined so as to be spaced apart from a terminal end1102 b of the tube 1102. In this example, the terminal end 1102 b of thetube 1102 is closed, such that the fluid from the fluid reservoir 160exits the tube 1102 at the fluid outlets 1110. The fluid outlets 1110,in this example, include two circular fluid outlets 1110 a, 1110 b;however, in some other examples, the fluid outlets 1110 may include anynumber of fluid outlets 1110 of any suitable shape. In this example, thefluid outlets 1110 a, 1110 b are spaced apart from each other and fromthe terminal end 1102 b. The fluid outlets 1110 a, 1110 b are definedthrough an outer surface 1102 c of the tube 1002 to enable fluiddelivery to the body of the user via the fluid delivery conduit 1006 awhen the proximalmost end 1102 a is inserted into the anatomy. In thisexample, the fluid outlets 1110 a, 1110 b are defined through the outersurface 1102 c on a side 1103 of the tube 1102 that is opposite a side1105 (FIG. 45) of the tube 1102 that defines the windows 1008. Bydefining the fluid outlets 1110 a, 1110 b on the side 1103 of the tube1102 opposite the side 1105 with the windows 1008, the dispensing of thefluid is positioned at a location within the anatomy that is differentand spaced apart from a location at which the glucose level is beingmeasured, which may improve accuracy of the physiological characteristicsensor 1000.

Referring back to FIG. 46, the reference electrode conduit 1006 baccommodates the reference electrode 740, the counter electrode conduit1006 c accommodates the counter electrode 742, and the working electrodeconduit 1006 d accommodates the working electrode 744 associated withthe physiological characteristic sensor 1000. The conduits 1006 b-1006 ddirect the respective electrodes 740, 742, 744 through the tube 1102 toa connector, such as the connector 702 of FIG. 39. Referring back toFIG. 45, the plurality of windows 1008 of the tube 1002 includes thereference electrode window 1008 b, the counter electrode window 1008 cand the working electrode window 1008 d. The windows 1008 b-1008 d areeach defined through the outer surface 1102 c of the tube 1102, andexpose the respective electrode 740, 742, 744 to interstitial fluid ofthe user when the proximalmost end 1102 a of the tube 1102 is insertedinto the anatomy.

In this example, the physiological characteristic sensor 1000 includesthe reference electrode 740, the counter electrode 742 and the workingelectrode 744. The chemical reaction between the glucose and the oxygenat the working electrode 744 generates an electrical signal, which istransmitted by the working electrode 744 and communicated to the controlmodule 822 of the fluid infusion device 800, as will be discussedfurther herein.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 48, thephysiological characteristic sensor 1000 is shown integrated with a tube1202. Insofar as the physiological characteristic sensor 1000 and thetube 1202 includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, and the physiological characteristic sensor 1000 and thetube 1002 discussed with regard to FIGS. 42-44, the same referencenumerals will be used to denote the same or similar components.

The tube 1202 may facilitate a fluidic connection between a connector,like the connector 702, and the infusion monitor unit 708, and aproximalmost end 1202 a of the tube 1202 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1202. The tube 1202 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc. In the example of FIG. 48, the tube 1202includes a plurality of conduits 1206 and a plurality of windows 1208.The plurality of conduits 1206 of the tube 1202 includes the fluiddelivery conduit 1006 a, a reference electrode conduit 1206 b, a counterelectrode conduit 1206 c and a working electrode conduit 1206 d. In thisexample, the conduits 1206 b-1206 d are spaced apart about a perimeteror circumference of the tube 1202, and thus, are spaced apart about aperimeter of the fluid delivery conduit 1006 a. The fluid deliveryconduit 1006 a receives the fluid from the fluid reservoir 160 anddirects the fluid from the fluid reservoir 160 through the tube 1202.The fluid delivery conduit 1006 a terminates at a terminal end 1202 b ofthe tube 1202, such that the terminal end 1202 b includes a fluid outlet1210.

The reference electrode conduit 1206 b accommodates the referenceelectrode 740 associated with the physiological characteristic sensor1000, and directs the reference electrode 740 through the tube 1202 to aconnector, such as the connector 702 of FIG. 39. The counter electrodeconduit 1206 c accommodates the counter electrode 742 associated withthe physiological characteristic sensor 1000, and directs the counterelectrode 742 through the tube 1202 to the connector, such as theconnector 702 of FIG. 39. The working electrode conduit 1206 daccommodates the working electrode 744 associated with the physiologicalcharacteristic sensor 1000, and directs the working electrode 744through the tube 1202 to the connector, such as the connector 702 ofFIG. 39.

The plurality of windows 1208 of the tube 1202 includes a referenceelectrode window 1208 b, a counter electrode window 1208 c and a workingelectrode window 1208 d. The reference electrode window 1208 b isdefined through an outer surface 1202 c of the tube 1202, and exposesthe reference electrode 740 to interstitial fluid of the user when theproximalmost end 1202 a of the tube 1202 is inserted into the anatomy.Generally, each of the windows 1208 b-1208 d is defined through theouter surface 1202 c such that the respective electrode 740, 742, 744 issufficiently exposed to the interstitial fluid. The counter electrodewindow 1208 c exposes the counter electrode 742 to interstitial fluid ofthe user when the proximalmost end 1202 a of the tube 1202 is insertedinto the anatomy. The working electrode window 1208 d exposes theworking electrode 744 to interstitial fluid of the user when theproximalmost end 1202 a of the tube 1202 is inserted into the anatomy.Each of the windows 1208 b-1208 d may be defined through the outersurface 1202 c of the tube 1202 for a respective length Le. In thisexample, each of the windows 1208 b-d has the same length Le.

The physiological characteristic sensor 1000 includes the referenceelectrode 740, the counter electrode 742 and the working electrode 744.The chemical reaction between the glucose and the oxygen at the workingelectrode 744 generates an electrical signal, which is transmitted bythe working electrode 744 and communicated to the control module 822 ofthe fluid infusion device 800, as will be discussed further herein.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIGS. 49-52, thephysiological characteristic sensor 1000 is shown being integrated witha tube 1249. Insofar as the physiological characteristic sensor 1000 andthe tube 1249 includes the same or similar components as thephysiological characteristic sensor 716 and the tube 706 discussed withregard to FIGS. 39-41, the physiological characteristic sensor 1000 andthe tube 1002 discussed with regard to FIGS. 42-44, the same referencenumerals will be used to denote the same or similar components.

In the example of FIG. 50, the tube 1249 facilitates a fluidicconnection between a connector, like the connector 702, and the infusionmonitor unit 708, and the proximalmost end 1249 a of the tube 1249 mayextend from the housing 710 and be inserted into an anatomy of a user toenable delivering the fluid, such as insulin, while also measuring aglucose level of the user. The connector is fluidly coupled to the fluidreservoir 160 such that the fluid reservoir 160 of the fluid infusiondevice 800 is a fluid source, which is fluidly connected to the tube1249. The physiological characteristic sensor 1000 is to be integratedwith the tube 1249 to measure a glucose level of the user. In thisexample, the physiological characteristic sensor 1000 is to beintegrated with the tube 1249 about its perimeter such that theinsertion of the proximalmost end 1249 a of the tube 1249 into theanatomy also inserts the physiological characteristic sensor 1000. Inthis example, the proximalmost end 1249 a of the tube 1249 is shown,along with the reference electrode 740, the counter electrode 742 andthe working electrode 744. The reference electrode 740, the counterelectrode 742 and the working electrode 744 are spaced apart about theperimeter of the tube 306. With reference to FIG. 51, a heat shrink tube1250 is disposed about the tube 1249, the reference electrode 740, thecounter electrode 742 and the working electrode 744. The heat shrinktube 1250 may be composed of any suitable polymer-based material, whichis capable of contracting (shrinking) upon heating from a first largediameter (FIG. 51) to a second, reduced diameter (FIG. 49). It should benoted that a heat shrink wrap may be used in place of the heat shrinktube 1250, and moreover, while the heat shrink tube 1250 is only shownsurrounding the proximalmost end 1249 a of the tube 1249, the heatshrink tube 1250 may be employed along the length of the tube 1249 tointegrate the physiological characteristic sensor 1000 with the tube1249 between the connector 702 and the proximalmost end 1249 a.

With reference to FIG. 49, once heat is applied to the heat shrink tube1250, the heat shrink tube 1250 contracts to integrate the physiologicalcharacteristic sensor 1000 with the tube 1249. As shown in FIG. 52, theheat shrink tube 1250 couples the reference electrode 740, the counterelectrode 742 and the working electrode 744 about the perimeter of thetube 1249. In this example, the heat shrink tube 1250 does not coverends 745 of the reference electrode 740, the counter electrode 742 andthe working electrode 744 such that the ends 745 of the referenceelectrode 740, the counter electrode 742 and the working electrode 744are exposed to the interstitial fluid to measure the glucose level ofthe user. As discussed, the chemical reaction between the glucose andthe oxygen at the working electrode 744 generates an electrical signal,which is transmitted by the working electrode 744 and communicated tothe control module 822 of the fluid infusion device 800, as will bediscussed further herein.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 53, aphysiological characteristic sensor (e.g. a glucose sensor) 1300 isshown proximate to but uncoupled with a tube 1301. As the physiologicalcharacteristic sensor 1300 and the tube 1301 includes the same orsimilar components as the physiological characteristic sensor 716 andthe tube 706 discussed with regard to FIGS. 39-41, the physiologicalcharacteristic sensor 1000 and the tube 1249 discussed with regard toFIGS. 49-52, the same reference numerals will be used to denote the sameor similar components.

The tube 1301 facilitates a fluidic connection between a connector, likethe connector 702, and the infusion monitor unit 708, and theproximalmost end 1301 a of the tube 1301 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1301. The physiologicalcharacteristic sensor 1300 is positioned proximate to the proximalmostend 1301 a of the tube 1301 to measure a glucose level of the user. Inthe example of FIG. 54, the physiological characteristic sensor 1300 isproximate to the proximalmost end 1301 a of the tube 1301 such that theinsertion of the proximalmost end 1301 a of the tube 1301 into theanatomy with a hollow needle 1304 also inserts the physiologicalcharacteristic sensor 1300 into the anatomy. Referring back to theexample of FIG. 53, the proximalmost end 1301 a of the tube 1301 isshown, along with the physiological characteristic sensor 1300. Thephysiological characteristic sensor 1300 is uncoupled with the tube 1301so as to be free floating relative to the tube 1301 once inserted intothe anatomy. Generally, the physiological characteristic sensor 1300 issized such that an end 1300 a of the physiological characteristic sensor1300 is spaced a distance D13 apart from a terminal end 1301 b of thetube 1301. The terminal end 1301 b includes a fluid outlet 1301 d (FIG.55). By spacing the end 1300 a of the physiological characteristicsensor 1300 away from the fluid outlet 1301 d of the tube 1301, theaccuracy of the physiological characteristic sensor 1300 may be improvedas the measurement of the glucose level and the delivery of fluid orinsulin are performed at different locations.

The physiological characteristic sensor 1300 may be is flexible. In theexample of FIG. 55, the physiological characteristic sensor 1300includes a reference electrode 1306, a counter electrode 1308 and aworking electrode 1310, which are physically and electrically coupled toa flexible substrate 1312. The working electrode 1310 may be coated withthe glucose oxidase enzyme. The reference electrode 1306 maintains aconstant voltage to support the reaction at working electrode 1310. Thecounter electrode 1308 supplies current to maintain the set potential onthe working electrode 1310. The electrodes 1306, 1308, 1310 may each becomposed of a suitable biocompatible metal or metal alloy, such ascopper, platinum, platinum-iridium, silver, gold, etc., and may beextruded. When glucose and oxygen diffuse to the glucose oxidase layer,hydrogen peroxide is formed. Hydrogen peroxide present at the workingelectrode 1310 metallization layer breaks down and generates electronswhen a voltage is applied to the working electrode 1310. These electronsgenerates an electrical signal, which is transmitted by the workingelectrode 1310 and communicated to the control module 822 of the fluidinfusion device 800, as will be discussed further herein. The substrate1312 may be flexible, and is composed of a suitable biocompatiblepolymeric based material, including, but not limited to polyethylene(PE), polyurethane (PU), polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene and silicone.

In order to deploy the tube 1301 and the physiological characteristicsensor 1300, the infusion monitor unit 708 may be pre-packaged with aninsertion instrument, such as the needle 1304 (FIG. 54) enveloping orsurrounding the physiological characteristic sensor 1300 and the tube1301. Once the infusion monitor unit 708 is coupled to the anatomy, viathe insertion instrument, the needle 1304 can be retracted, leaving thephysiological characteristic sensor 1300 and the tube 1301 inserted intothe anatomy. In the example of FIG. 55, the physiological characteristicsensor 1300 is positioned proximate to the tube 1301 such that theelectrodes 1306, 1308, 1310 face away from the tube 1301.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 56, thephysiological characteristic sensor 1300 is shown integrated within atube 1402. Insofar as the physiological characteristic sensor 1300 andthe tube 1402 includes the same or similar components as thephysiological characteristic sensor 716 and the tube 706 discussed withregard to FIGS. 39-41, the physiological characteristic sensor 1000 andthe tube 1102 discussed with regard to FIGS. 45-47, and thephysiological characteristic sensor 1300 discussed with regard to FIGS.53-55, the same reference numerals will be used to denote the same orsimilar components.

The tube 1402 may facilitate a fluidic connection between a connector,like the connector 702, and the infusion monitor unit 708, and aproximalmost end 1402 a of the tube 1402 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1402. The tube 1402 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc. In some examples, the tube 1402 includes aplurality of conduits 1406 and a window 1408.

The plurality of conduits 1406 of the tube 1402 includes a fluiddelivery conduit 1406 a and a sensor conduit 1406 b. The fluid deliveryconduit 1406 a receives the fluid from the fluid reservoir 160 anddirects the fluid from the fluid reservoir 160 through the tube 1402. Insome embodiments, the fluid delivery conduit 1406 a includes one or morefluid outlets 1410. For example, the fluid delivery conduit 1406 aincludes a plurality of fluid outlets 1410. The plurality of fluidoutlets 1410 includes a first fluid outlet 1410 a and a second fluidoutlet 1410 b. In this example, the terminal end 1402 b of the tube 1402includes the fluid outlet 1410 a, and the fluid outlet 1410 b is definedthrough an outer surface 1402 c of the tube 1402 and connected to thefluid delivery conduit 1406 a. The fluid outlet 1410 b is defined so asto be spaced apart from a terminal end 1402 b of the tube 1402. Thefluid from the fluid reservoir 160 exits the tube 1402 at the fluidoutlet 1410 b and at the fluid outlet 1410 a at the terminal end 1402 b.The fluid outlets 1410, in this example, include two circular fluidoutlets 1410 a, 1410 b; however, in some other examples, the fluidoutlets 1410 may include any number of fluid outlets 1410 of any shape.In this example, the fluid outlets 1410 a, 1410 b are spaced apart fromeach other. In this example, the fluid outlet 1410 b is defined throughthe outer surface 1402 c on a side 1412 of the tube 1402 that isopposite a side 1414 of the tube 1402 in which the window 1408 isdefined. By defining the fluid outlet 1410 b on the side 1412 of thetube 1402 opposite the side 1414 with the window 1008, the dispensing ofthe fluid is positioned at a location within the anatomy that isdifferent and spaced apart from a location at which the glucose level isbeing measured, which may improve accuracy of the physiologicalcharacteristic sensor 1300.

Referring back to the example of FIG. 56, the window 1408 of the tube1402 is defined through the outer surface 1402 c of the tube 1402, andexposes the electrodes 1306, 1308, 1310 of the physiologicalcharacteristic sensor 1300 to the interstitial fluid of the user whenthe proximalmost end 1402 a of the tube 1202 is inserted into theanatomy. The window 1408 is defined through the outer surface 1402 c toexpose the electrodes 1306, 1308, 1310 to the interstitial fluid. Thus,the electrodes 1306, 1308, 1310 face the window 1408, and face away fromthe fluid outlet 1410 b.

In this example, the physiological characteristic sensor 1300 includesthe reference electrode 1306, the counter electrode 1308 and the workingelectrode 1310. The chemical reaction between the glucose and the oxygenat the working electrode 1310 generates an electrical signal, which istransmitted by the working electrode 1310 and communicated to thecontrol module 822 of the fluid infusion device 800, as will bediscussed further herein.

In order to deploy the tube 1402 and the physiological characteristicsensor 1300, the infusion monitor unit 708 may be pre-packaged with aninsertion instrument, such as the needle 1304 of FIG. 58. The needle1304 envelops or surrounds the tube 1402, which includes thephysiological characteristic sensor 1300. Once the infusion monitor unit708 is coupled to the anatomy, via the insertion instrument, the needle1304 can be retracted, leaving the physiological characteristic sensor1300 and the tube 1402 inserted into the anatomy.

Alternatively, in order to deploy the tube 1402 and the physiologicalcharacteristic sensor 1300, the infusion monitor unit 708 may bepre-packaged with an insertion instrument, such as a closed tip needle1420 (FIG. 59) that extends through the fluid delivery conduit 1406 aand exits at the proximalmost end 1402 a of the tube 1402. Theproximalmost end 1402 a of the tube 1402 may include an access opening,which may be sealed by a septum within the infusion monitor unit 708, toseal the opening once the needle 1420 is removed. The needle 1420 may beinserted through the proximalmost end 1402 a of the tube 1402. Once theinfusion monitor unit 708 is coupled to the anatomy, via the insertioninstrument, the needle 1420 can be retracted, leaving the physiologicalcharacteristic sensor 1300 and the tube 1402 inserted into the anatomy.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 60, thephysiological characteristic sensor 1300 is shown integrated with a tube1449. As the physiological characteristic sensor 1300 and the tube 1449includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, the physiological characteristic sensor 1000 and the tube1002 discussed with regard to FIGS. 42-44, and the physiologicalcharacteristic sensor 1300 discussed with regard to FIGS. 53-55, thesame reference numerals will be used to denote the same or similarcomponents.

The tube 1449 may facilitate a fluidic connection between a connector,like the connector 702, and the infusion monitor unit 708, and theproximalmost end 1449 a of the tube 1449 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1449. The physiologicalcharacteristic sensor 1300 is to be integrated with the proximalmost end1449 a of the tube 1449 to measure a glucose level of the user. In thisexample, the physiological characteristic sensor 1300 is to beintegrated with the tube 1449 along an outer surface 1449 c such thatthe insertion of the proximalmost end 1449 a of the tube 1449 into theanatomy also inserts the physiological characteristic sensor 1300. Inthis example, the proximalmost end 1449 a of the tube 1449 is shown,along with the physiological characteristic sensor 1300. A heat shrinktube 1450 is disposed about the tube 1449 and the physiologicalcharacteristic sensor 1300. The heat shrink tube 1450 may be composed ofany suitable polymer-based material, which is capable of contracting(shrinking) upon heating from a first large diameter to a second,reduced diameter. It should be noted that a heat shrink wrap may be usedin place of the heat shrink tube 1450, and moreover, while the heatshrink tube 1450 is only shown surrounding the proximalmost end 1449 aof the tube 1449, the heat shrink tube 1450 may be employed along thelength of the tube 1449 to integrate the physiological characteristicsensor 1300 with the tube 1449 between the connector 702 and theproximalmost end 1449 a. In this example, the heat shrink tube 1450defines a window 1452, which enables the electrodes 1306, 1308, 1310 ofthe physiological characteristic sensor 1300 to contact the interstitialfluid when the proximalmost end 1449 a is inserted into the anatomy. Thewindow 1452 is defined through the heat shrink tube 1450 with a lengthsufficient enough to expose each of the electrodes 1306, 1308, 1310.Generally, the physiological characteristic sensor 1300 is sized suchthat the end 1300 a of the physiological characteristic sensor 1300 isspaced a distance apart from a terminal end 306 b of the tube 306. Theterminal end 1449 b defines the fluid outlet 1449 d. By spacing the end1300 a of the physiological characteristic sensor 1300 away from thefluid outlet 1449 d of the tube 1449, the accuracy of the physiologicalcharacteristic sensor 1300 may be improved as the measurement of theblood glucose level is spaced apart from the delivered fluid or insulin.

Once heat is applied to the heat shrink tube 1450, the heat shrink tube1450 contracts to integrate the physiological characteristic sensor 1300with the tube 1449 while leaving the electrodes 1306, 1308, 1310 exposedto the interstitial fluid to measure the blood glucose level of theuser. The heat shrink tube 1450 couples the physiological characteristicsensor 1300 to the perimeter of the tube 1449. The chemical reactionbetween the glucose and the oxygen at the working electrode 1310generates an electrical signal, which is transmitted by the workingelectrode 1310 and communicated to the control module 822 of the fluidinfusion device 800, as will be discussed further herein.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 61, thephysiological characteristic sensor 1300 is shown integrated within atube 1502. As the physiological characteristic sensor 1300 and the tube1502 includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, the physiological characteristic sensor 1300 discussed withregard to FIGS. 53-55, and the physiological characteristic sensor 1300and the tube 1402 discussed with regard to FIGS. 56-59, the samereference numerals will be used to denote the same or similarcomponents.

The tube 1502 may facilitate a fluidic connection between a connector,like the connector 702, and the infusion monitor unit 708, and aproximalmost end 1502 a of the tube 1502 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1502. The tube 1502 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc. In some examples, the tube 1502 includes aplurality of conduits 1506 and a window 1508. The tube 1502 alsoincludes a beveled surface 1510 at a terminal end 1502 b for ease ofinsertion into the anatomy.

With reference to FIG. 62, the plurality of conduits 1506 of the tube1502 includes a fluid delivery conduit 1506 a and an electrode conduit1506 b. The fluid delivery conduit 1506 a receives the fluid from thefluid reservoir 160 and directs the fluid from the fluid reservoir 160through the tube 1502. In some examples, the fluid delivery conduit 1506a includes at least one fluid outlet 1512. In this example, the terminalend 1502 b of the tube 1502 is opened to define the fluid outlet 1512.The fluid from the fluid reservoir 160 exits the tube 1502 at the fluidoutlet 1512 at the terminal end 1502 b. In this example, the fluidoutlet 1512 is circular. In this example, the fluid outlet 1512 isdefined at the terminal end 1502 b to be spaced a distance apart fromthe physiological characteristic sensor 1300. By spacing the fluidoutlet 1512 from the physiological characteristic sensor 1300, thedispensing of the fluid is positioned at a location within the anatomythat is different and spaced apart from a location at which the bloodglucose level is being measured, which may improve accuracy of thephysiological characteristic sensor 1300. The electrode conduit 1506 baccommodates the physiological characteristic sensor 1300. In thisexample, the electrode conduit 1506 b is oval shaped, however, theelectrode conduit 1506 b may have any desired shape.

With reference to FIG. 63, the window 1508 of the tube 1502 is definedthrough the outer surface 1502 c of the tube 1502, and exposes theelectrodes 1306, 1308, 1310 of the physiological characteristic sensor1300 to the interstitial fluid of the user when the proximalmost end1502 a of the tube 1502 is inserted into the anatomy. The window 1508may be defined via laser cutting, for example. Generally, the window1508 is defined through the outer surface 1502 c to expose therespective electrode 1306, 1308, 1310 to the interstitial fluid. Thus,the electrodes 1306, 1308, 1310 face the window 1508 to measure theblood glucose level of the user.

In this example, the physiological characteristic sensor 1300 includesthe reference electrode 1306, the counter electrode 1308 and the workingelectrode 1310. The chemical reaction between the glucose and the oxygenat the working electrode 1310 generates an electrical signal, which istransmitted by the working electrode 1310 and communicated to thecontrol module 822 of the fluid infusion device 800, as will bediscussed further herein. In some examples, an end 1300 a (FIG. 62) ofthe physiological characteristic sensor 1300 may be coupled to theelectrode conduit 1506 b to further secure the physiologicalcharacteristic sensor 1300 within the electrode conduit 1506 b, viaadhesives, heat bonding, etc.

In order to deploy the tube 1502 and the physiological characteristicsensor 1300, the infusion monitor unit 708 may be pre-packaged with aninsertion instrument, such as a needle 1514. The needle 1514 extendsthrough the fluid delivery conduit 1506 a and exits at the proximalmostend 1502 a of the tube 1502. In this example, the proximalmost end 1502a of the tube 1502 may include an access opening, which may be sealed bya septum within the infusion monitor unit 708, to seal the opening oncethe needle 1514 is removed. Once the infusion monitor unit 708 iscoupled to the anatomy, via the insertion instrument, the needle 1514can be retracted, leaving the physiological characteristic sensor 1300and the tube 1502 inserted into the anatomy. In some examples, theneedle 1514 is a 26 gauge needle, however, other sizes may be employedthat correspond to the fluid delivery conduit 1506 a.

Alternatively, with reference to FIG. 64, in order to deploy the tube1502 and the physiological characteristic sensor 1300, the infusionmonitor unit 708 may be pre-packaged with an insertion instrument, suchas a half needle 1530 that extends through the fluid delivery conduit1506 a and exits at the proximalmost end 1502 a of the tube 1502. Inthis example, the proximalmost end 1502 a of the tube 1502 may includean access opening, which may be sealed by a septum within the infusionmonitor unit 708, to seal the opening once the needle 1520 is removed.With reference to FIG. 65, the use of the half needle 1530 (which is theneedle 1514 cut in half) enables a diameter of the fluid deliveryconduit 1506 a to be reduced, which results in the tube 1502 having asmaller diameter than that shown in FIGS. 61-63. The needle 1530 isinserted through the proximalmost end 1502 a of the tube 1502 as shownin FIG. 66. Once the infusion monitor unit 708 is coupled to theanatomy, via the insertion instrument, the needle 1530 can be retracted,leaving the physiological characteristic sensor 1300 and the tube 1502inserted into the anatomy.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIGS. 67 and 68,the physiological characteristic sensor 1300 is shown integrated withina tube 1552. As the physiological characteristic sensor 1300 and thetube 1552 includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, the physiological characteristic sensor 1300 discussed withregard to FIGS. 53-55, and the physiological characteristic sensor 1300and the tube 1502 discussed with regard to FIGS. 61-66, the samereference numerals will be used to denote the same or similarcomponents.

The tube 1552 may facilitate a fluidic connection between a connector,like the connector 702, and the infusion monitor unit 708, and aproximalmost end 1552 a of the tube 1552 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1552. The tube 1552 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc. In some examples, the tube 1552 includes aplurality of conduits 1556 and a window 1558.

With reference to FIG. 68, the plurality of conduits 1556 of the tube1552 includes a fluid delivery conduit 1556 a and an electrode conduit1556 b. The fluid delivery conduit 1556 a receives the fluid from thefluid reservoir 160 and directs the fluid from the fluid reservoir 160through the tube 1552. In some examples, the fluid delivery conduit 1556a includes at least one fluid outlet 1562. In this example, the terminalend 1552 b of the tube 1552 is opened to define the fluid outlet 1562.The fluid from the fluid reservoir 160 exits the tube 1552 at the fluidoutlet 1562 at the terminal end 1552 b. In this example, the fluidoutlet 1562 is oval shaped, and has a major diameter MD that isdifferent and less than a major diameter MD2 of the electrode conduit1556 b. The minor diameter of the fluid delivery conduit 1556 a is alsodifferent, and less than, the minor diameter of the electrode conduit1556 b. In this example, the fluid outlet 1562 is defined at theterminal end 1552 b to be spaced a distance apart from the physiologicalcharacteristic sensor 1300. By spacing the fluid outlet 1562 from thephysiological characteristic sensor 1300, the dispensing of the fluid ispositioned at a location within the anatomy that is different and spacedapart from a location at which the glucose level is being measured,which may improve accuracy of the physiological characteristic sensor1300. The electrode conduit 1556 b accommodates the physiologicalcharacteristic sensor 1300. In this example, the electrode conduit 1556b is oval shaped, however, the electrode conduit 1556 b may have anydesired shape. In this example, the use of the oval shape for theconduits 1556 a, 1556 b reduces a size of the tube 1552 so that it issubstantially contained within a needle 1564 (FIG. 69).

With reference to FIG. 67, the window 1558 of the tube 1552 is definedthrough the outer surface 1552 c of the tube 1552, and exposes theelectrodes 1306, 1308, 1310 of the physiological characteristic sensor1300 to the interstitial fluid of the user when the proximalmost end1552 a of the tube 1552 is inserted into the anatomy. The window 1558may be defined via laser cutting, for example. Generally, the window1558 is defined through the outer surface 1552 c to expose theelectrodes 1306, 1308, 1310 to the interstitial fluid. Thus, theelectrodes 1306, 1308, 1310 face the window 1558 to measure the bloodglucose level of the user and are positioned on a side of the tube 1552that is opposite the fluid delivery conduit 1556 a.

In this example, the physiological characteristic sensor 1300 includesthe reference electrode 1306, the counter electrode 1308 and the workingelectrode 1310. The chemical reaction between the glucose and the oxygenat the working electrode 1310 generates an electrical signal, which istransmitted by the working electrode 1310 and communicated to thecontrol module 822 of the fluid infusion device 800, as will bediscussed further herein. In some examples, an end 1300 a (FIG. 68) ofthe physiological characteristic sensor 1300 may be coupled to theelectrode conduit 1556 b to further secure the physiologicalcharacteristic sensor 1300 within the electrode conduit 1556 b, viaadhesives, heat bonding, etc.

In order to deploy the tube 1552 and the physiological characteristicsensor 1300, the infusion monitor unit 708 may be pre-packaged with aninsertion instrument, such as a needle 1564. The needle 1564 surroundsthe tube 1552, which includes the physiological characteristic sensor1300. Once the infusion monitor unit 708 is coupled to the anatomy, viathe insertion instrument, the needle 1564 can be retracted, leaving thephysiological characteristic sensor 1300 and the tube 1552 inserted intothe anatomy as shown in FIG. 67.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 70, thephysiological characteristic sensor 1300 is shown integrated within atube 1602. As the physiological characteristic sensor 1300 and the tube1602 includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, the physiological characteristic sensor 1300 discussed withregard to FIGS. 53-55, and the physiological characteristic sensor 1300and the tube 1502 discussed with regard to FIGS. 61-66, the samereference numerals will be used to denote the same or similarcomponents.

The tube 1602 may facilitate a fluidic connection between a connector,like the connector 702, and the infusion monitor unit 708, and aproximalmost end 1602 a of the tube 1602 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1602. The tube 1602 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc. In some examples, the tube 1602 includes aplurality of conduits 1606 and a window 1608.

With reference to FIG. 71, the plurality of conduits 1606 of the tube1602 includes a fluid delivery conduit 1606 a and an electrode conduit1606 b. The fluid delivery conduit 1606 a receives the fluid from thefluid reservoir 160 and directs the fluid from the fluid reservoir 160through the tube 1602. In some examples, the fluid delivery conduit 1606a includes at least one fluid outlet 1612. In this example, the terminalend 1602 b of the tube 1602 is circumferentially opened to define thefluid outlet 1612. The fluid from the fluid reservoir 160 exits the tube1602 at the fluid outlet 1612 at the terminal end 1602 b. In thisexample, the fluid outlet 1612 is circular, and has a diameter D16 thatis different and less than a major diameter MD16 of the electrodeconduit 1606 b. In this example, the fluid outlet 1612 is defined at theterminal end 1602 b to be spaced a distance apart from the physiologicalcharacteristic sensor 1300. By spacing the fluid outlet 1612 from thephysiological characteristic sensor 1300, the dispensing of the fluid ispositioned at a location within the anatomy that is different and spacedapart from a location at which the blood glucose level is beingmeasured, which may improve accuracy of the physiological characteristicsensor 1300. The electrode conduit 1606 b accommodates the physiologicalcharacteristic sensor 1300 and is positioned along a side of the fluiddelivery conduit 1606 a. In this example, the electrode conduit 1606 bis oval shaped, however, the electrode conduit 1606 b may have anydesired shape. In this example, the use of the oval shape for theelectrode conduit 1606 b reduces a size of the tube 1602 so that it issubstantially contained within a needle 1614.

With reference to FIG. 70, the window 1608 of the tube 1602 is definedthrough the outer surface 1602 c of the tube 1602, and exposes theelectrodes 1306, 1308, 1310 of the physiological characteristic sensor1300 to the interstitial fluid of the user when the proximalmost end1602 a of the tube 1602 is inserted into the anatomy. The window 1608may be defined via laser cutting, for example. Generally, the window1608 is defined through the outer surface 1602 c to expose therespective electrode 1306, 1308, 1310 to the interstitial fluid. Thus,the electrodes 1306, 1308, 1310 face the window 1608 to measure theblood glucose level of the user and are positioned on a side of the tube1602 that is opposite the fluid delivery conduit 1606 a.

In this example, the physiological characteristic sensor 1300 includesthe reference electrode 1306, the counter electrode 1308 and the workingelectrode 1310. The chemical reaction between the glucose and the oxygenat the working electrode 1310 generates an electrical signal, which istransmitted by the working electrode 1310 and communicated to thecontrol module 822 of the fluid infusion device 800, as will bediscussed further herein. In some examples, an end 1300 a (FIG. 71) ofthe physiological characteristic sensor 1300 may be coupled to theelectrode conduit 1606 b to further secure the physiologicalcharacteristic sensor 1300 within the electrode conduit 1606 b, viaadhesives, heat bonding, etc.

In order to deploy the tube 1602 and the physiological characteristicsensor 1300, the infusion monitor unit 708 may be pre-packaged with aninsertion instrument, such as the needle 1614. The needle 1614 surroundsthe tube 1602, which includes the physiological characteristic sensor1300. Once the infusion monitor unit 708 is coupled to the anatomy, viathe insertion instrument, the needle 1614 can be retracted, leaving thephysiological characteristic sensor 1300 and the tube 1602 inserted intothe anatomy.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 72, thephysiological characteristic sensor 1300 is shown integrated within atube 1652. As the physiological characteristic sensor 1300 and the tube1652 includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, the physiological characteristic sensor 1300 discussed withregard to FIGS. 53-55, and the physiological characteristic sensor 1300and the tube 1502 discussed with regard to FIGS. 61-66, the samereference numerals will be used to denote the same or similarcomponents.

The tube 1652 may facilitate a fluidic connection between a connector,like the connector 702, and the infusion monitor unit 708, and aproximalmost end 1652 a of the tube 1652 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1652. The tube 1652 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc. In some examples, the tube 1652 includes aplurality of conduits 1656 and a slot 1658.

With reference to FIG. 73, the plurality of conduits 1656 of the tube1652 includes a fluid delivery conduit 1656 a and an electrode conduit1656 b. The fluid delivery conduit 1656 a receives the fluid from thefluid reservoir 160 and directs the fluid from the fluid reservoir 160through the tube 1652. In some examples, the fluid delivery conduit 1656a includes at least one fluid outlet 1662. In this example, the terminalend 1652 b of the tube 1652 is opened to define the fluid outlet 1662.The fluid from the fluid reservoir 160 exits the tube 1652 at the fluidoutlet 1662 at the terminal end 1652 b. In this example, the fluidoutlet 1662 is oval-shaped, and has a major diameter MD17 that isdifferent and less than a width W18 of the electrode conduit 1656 b. Inthis example, the fluid outlet 1662 is defined at the terminal end 1652b to be spaced a distance apart from the physiological characteristicsensor 1300. By spacing the fluid outlet 1662 from the physiologicalcharacteristic sensor 1300, the dispensing of the fluid is positioned ata location within the anatomy that is different and spaced apart from alocation at which the blood glucose level is being measured, which mayimprove accuracy of the physiological characteristic sensor 1300. Theelectrode conduit 1656 b accommodates the physiological characteristicsensor 1300 and is positioned along a side of the fluid delivery conduit1656 a. In this example, the electrode conduit 1656 b is semi-ovalshaped, however, the electrode conduit 1656 b may have any desiredshape. In this example, the shape of the conduits 1656 a, 1656 b reducesa size of the tube 1652 so that it is substantially contained within aneedle 1664.

The slot 1658 of the tube 1652 is defined through the outer surface 1652c (FIG. 72) of the tube 1652, and with reference to FIG. 72, exposes theelectrodes 1306, 1308, 1310 of the physiological characteristic sensor1300 to the interstitial fluid of the user when the proximalmost end1652 a of the tube 1652 is inserted into the anatomy. The slot 1658 maybe defined via laser cutting, for example. Generally, the slot 1658 isdefined through the outer surface 1652 c and extends along a length ofthe tube 1652. The slot 1658 exposes the respective electrode 1306,1308, 1310 to the interstitial fluid. Thus, the electrodes 1306, 1308,1310 face the slot 1658 to measure the glucose level of the user and arepositioned on a side of the tube 1652 that is opposite the fluiddelivery conduit 1656 a.

In this example, the physiological characteristic sensor 1300 includesthe reference electrode 1306, the counter electrode 1308 and the workingelectrode 1310. The chemical reaction between the glucose and the oxygenat the working electrode 1310 generates an electrical signal, which istransmitted by the working electrode 1310 and communicated to thecontrol module 822 of the fluid infusion device 800, as will bediscussed further herein. In some examples, with reference to FIG. 74,an end 1300 a of the physiological characteristic sensor 1300 may becoupled to the electrode conduit 1656 b to further secure thephysiological characteristic sensor 1300 within the electrode conduit1656 b, via adhesives, heat bonding, etc. In addition, the physiologicalcharacteristic sensor 1300 may be coupled to the electrode conduit 1656b, via adhesives, heat bonding, etc., at various points along a lengthof the physiological characteristic sensor 1300 to retain thephysiological characteristic sensor 1300 in the slot 1658.

In order to deploy the tube 1652 and the physiological characteristicsensor 1300, the infusion monitor unit 708 may be pre-packaged with aninsertion instrument, such as the needle 1664. The needle 1664 envelopsor surrounds the tube 1652, which includes the physiologicalcharacteristic sensor 1300. Once the infusion monitor unit 708 iscoupled to the anatomy, via the insertion instrument, the needle 1664can be retracted, leaving the physiological characteristic sensor 1300and the tube 1652 inserted into the anatomy.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 75, thephysiological characteristic sensor 1300 is shown integrated within atube 1702. As the physiological characteristic sensor 1300 and the tube1702 includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, the physiological characteristic sensor 1300 discussed withregard to FIGS. 53-55, and the physiological characteristic sensor 1300and the tube 1502 discussed with regard to FIGS. 61-66, the samereference numerals will be used to denote the same or similarcomponents.

The tube 1702 may facilitate a fluidic connection between a connector,like the connector 702, and the infusion monitor unit 708, and aproximalmost end 1702 a of the tube 1702 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1702. The tube 1702 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc. In some examples, the tube 1702 includes aplurality of conduits 1706 and a slot 1708.

With reference to FIG. 76, the plurality of conduits 1706 of the tube1702 includes a fluid delivery conduit 1706 a and an electrode conduit1706 b. The fluid delivery conduit 1706 a receives the fluid from thefluid reservoir 160 and directs the fluid from the fluid reservoir 160through the tube 1702. In some examples, the fluid delivery conduit 1706a includes at least one fluid outlet 1712. In this example, the terminalend 1702 b of the tube 1702 is circumferentially opened to define thefluid outlet 1712. The fluid from the fluid reservoir 160 exits the tube1702 at the fluid outlet 1712 at the terminal end 1702 b. In thisexample, the fluid outlet 1712 is defined at the terminal end 1702 b tobe spaced a distance apart from the physiological characteristic sensor1300. By spacing the fluid outlet 1712 from the physiologicalcharacteristic sensor 1300, the dispensing of the fluid is positioned ata location within the anatomy that is different and spaced apart from alocation at which the glucose level is being measured, which may improveaccuracy of the physiological characteristic sensor 1300. The electrodeconduit 1706 b receives the physiological characteristic sensor 1300 andis positioned along a side of the fluid delivery conduit 1706 a so thatthe tube 1702 is receivable within a needle 1714. In this example, theelectrode conduit 1706 b is slotted, however, the electrode conduit 1706b may have any desired shape.

The slot 1708 of the tube 1652 is defined through the outer surface 1702c of the tube 1702, and with reference to FIG. 75, exposes theelectrodes 1306, 1308, 1310 of the physiological characteristic sensor1300 to the interstitial fluid of the user when the proximalmost end1702 a of the tube 1702 is inserted into the anatomy. The slot 1708 maybe defined via laser cutting, for example. Generally, the slot 1708 isdefined through the outer surface 1702 c and extends for a length of thetube 1702 to expose the electrodes 1306, 1308, 1310 to the interstitialfluid. Thus, the electrodes 1306, 1308, 1310 face the slot 1708 tomeasure the blood glucose level of the user. In some examples, withreference to FIG. 77, the tube 1702 may also include a window 1709defined adjacent to the slot 1708 to increase the exposure of theelectrodes 1306, 1308, 1310. The window 1709 may be formed by lasercutting, for example.

It should be noted in other examples, the slot 1708 may be configureddifferently to expose the electrodes 1306, 1308, 1310. For example, withreference to FIG. 78, the tube 1702 is shown with a slot 1708′. The slot1708′ is defined through the outer surface 1702 c such that an entiretyof the physiological characteristic sensor 1300 is exposed over a lengthof the physiological characteristic sensor 1300. The slot 1708 may bedefined via laser cutting, for example. Generally, the slot 1708 isdefined through the outer surface 1702 c and extends for a length of thetube 1702 to expose the electrodes 1306, 1308, 1310 to the interstitialfluid.

The physiological characteristic sensor 1300 includes the referenceelectrode 1306, the counter electrode 1308 and the working electrode1310. The chemical reaction between the glucose and the oxygen at theworking electrode 1310 generates an electrical signal, which istransmitted by the working electrode 1310 and communicated to thecontrol module 822 of the fluid infusion device 800, as will bediscussed further herein. In some examples, with reference to FIGS. 76and 78, an end 1300 a of the physiological characteristic sensor 1300may be coupled to the electrode conduit 1706 b at various locationsalong a length of the physiological characteristic sensor 1300 tofurther secure the physiological characteristic sensor 1300 within theelectrode conduit 1706 b, via adhesives, heat bonding, etc.

In this example, in order to deploy the tube 1702 and the physiologicalcharacteristic sensor 1300, the infusion monitor unit 708 may bepre-packaged with an insertion instrument, such as the needle 1714. Theneedle 1714 envelops or surrounds the tube 1702, which includes thephysiological characteristic sensor 1300. Once the infusion monitor unit708 is coupled to the anatomy, via the insertion instrument, the needle1714 can be retracted, leaving the physiological characteristic sensor1300 and the tube 1702 inserted into the anatomy.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 79, thephysiological characteristic sensor 1300 is shown integrated within atube 1752. As the physiological characteristic sensor 1300 and the tube1752 includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, the physiological characteristic sensor 1300 discussed withregard to FIGS. 53-55, and the physiological characteristic sensor 1300and the tube 1652 discussed with regard to FIGS. 72-74, the samereference numerals will be used to denote the same or similarcomponents.

The tube 1752 may facilitate a fluidic connection between a connector,like the connector 702, with the infusion monitor unit 708, and aproximalmost end 1752 a of the tube 1752 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1752. The tube 1752 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc. In some examples, the tube 1752 includes aplurality of conduits 1756 and a slot 1758.

With reference to FIG. 80, the plurality of conduits 1756 of the tube1752 includes a fluid delivery conduit 1756 a and an electrode conduit1756 b. The fluid delivery conduit 1756 a receives the fluid from thefluid reservoir 160 and directs the fluid from the fluid reservoir 160through the tube 1752. In some examples, the fluid delivery conduit 1756a includes at least one fluid outlet 1762. In this example, the terminalend 1752 b of the tube 1752 is opened to define the fluid outlet 1762.The fluid from the fluid reservoir 160 exits the tube 1752 at the fluidoutlet 1762 at the terminal end 1752 b. In this example, the fluidoutlet 1762 is circular, and has a diameter D20 that is different andless than a width W20 of the electrode conduit 1756 b. In this example,the fluid outlet 1762 is defined at the terminal end 1752 b to be spaceda distance apart from the physiological characteristic sensor 1300. Byspacing the fluid outlet 1762 from the physiological characteristicsensor 1300, the dispensing of the fluid is positioned at a locationwithin the anatomy that is different and spaced apart from a location atwhich the glucose level is being measured, which may improve accuracy ofthe physiological characteristic sensor 1300. The electrode conduit 1756b receives the physiological characteristic sensor 1300 and ispositioned along a side of the fluid delivery conduit 1756 a. In thisexample, the electrode conduit 1756 b is semi-oval shaped, however, theelectrode conduit 1756 b may have any desired shape. In this example,the shape of the conduits 1756 a, 1756 b reduces a size of the tube 1752so that it is substantially contained within a needle 1764.

The slot 1758 of the tube 1752 is defined through the outer surface 1752c of the tube 1752, and with reference to FIG. 79, exposes theelectrodes 1306, 1308, 1310 of the physiological characteristic sensor1300 to the interstitial fluid of the user when the proximalmost end1752 a of the tube 1752 is inserted into the anatomy. The slot 1758 maybe defined via laser cutting, for example. Generally, the slot 1758 isdefined through the outer surface 1752 c and extends along a length ofthe tube 1752. The slot 1758 exposes the respective electrode 1306,1308, 1310 to the interstitial fluid. Thus, the electrodes 1306, 1308,1310 face the slot 1658 to measure the blood glucose level of the userand are positioned on a side of the tube 1752 that is opposite the fluiddelivery conduit 1756 a.

The physiological characteristic sensor 1300 includes the referenceelectrode 1306, the counter electrode 1308 and the working electrode1310. The chemical reaction between the glucose and the oxygen at theworking electrode 1310 generates an electrical signal, which istransmitted by the working electrode 1310 and communicated to thecontrol module 822 of the fluid infusion device 800, as will bediscussed further herein. In some examples, with reference to FIG. 81,an end 1300 a of the physiological characteristic sensor 1300 may becoupled to the electrode conduit 1756 b to further secure thephysiological characteristic sensor 1300 within the electrode conduit1756 b, via adhesives, heat bonding, etc. In addition, the physiologicalcharacteristic sensor 1300 may be coupled to the electrode conduit 1756b, via adhesives, heat bonding, etc., at various points along a lengthof the physiological characteristic sensor 1300 to retain thephysiological characteristic sensor 1300 in the slot 1758.

In order to deploy the tube 1652 and the physiological characteristicsensor 1300, the infusion monitor unit 708 may be pre-packaged with aninsertion instrument, such as the needle 1764. The needle 1764 envelopsor surrounds the tube 1752, which includes the physiologicalcharacteristic sensor 1300. Once the infusion monitor unit 708 iscoupled to the anatomy, via the insertion instrument, the needle 1764can be retracted, leaving the physiological characteristic sensor 1300and the tube 1752 inserted into the anatomy.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 82, aphysiological characteristic sensor (e.g. glucose sensor) 1800 is shownintegrated within a tube 1802. As the physiological characteristicsensor 1800 and the tube 1802 includes the same or similar components asthe physiological characteristic sensor 716 and the tube 706 discussedwith regard to FIGS. 39-41, the physiological characteristic sensor 1000and the tube 1102 discussed with regard to FIGS. 45-47, and thephysiological characteristic sensor 1300 and the tube 1652 discussedwith regard to FIGS. 72-74, the same reference numerals will be used todenote the same or similar components.

The tube 1802 may facilitate a fluidic connection between a connector,like the connector 702, with the infusion monitor unit 708, and aproximalmost end 1802 a of the tube 1802 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1802. The tube 1802 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc. In some examples, the tube 1802 includes aplurality of conduits 1806 and a plurality of windows 1808.

With reference to FIG. 83, the plurality of conduits 1806 of the tube1802 includes a fluid delivery conduit 1806 a, the reference electrodeconduit 1806 b, the counter electrode conduit 1806 c, the workingelectrode conduit 1806 d and an additional electrode conduit 1806 e. Thefluid delivery conduit 1806 a receives the fluid from the fluidreservoir 160 and directs the fluid from the fluid reservoir 160 throughthe tube 1802. In this example, the fluid outlet 1812 is defined at theterminal end 1802 b to be spaced a distance apart from the physiologicalcharacteristic sensor 1800. By spacing the fluid outlet 1812 from thephysiological characteristic sensor 1800, the dispensing of the fluid ispositioned at a location within the anatomy that is different and spacedapart from a location at which the blood glucose level is beingmeasured, which may improve accuracy of the physiological characteristicsensor 1800.

The reference electrode conduit 1806 b accommodates the referenceelectrode 740, the counter electrode conduit 1806 c accommodates thecounter electrode 742, and the working electrode conduit 1806 daccommodates the working electrode 744 associated with the physiologicalcharacteristic sensor 1800. The additional electrode conduit 1806 eaccommodates an additional electrode 1820 associated with thephysiological characteristic sensor 1800. The conduits 1806 b-1806 edirect the respective electrodes 740, 742, 744, 1820 through the tube1802 to the connector 702 (FIG. 39). The plurality of windows 1808 ofthe tube 1802 includes the reference electrode window 1808 b, thecounter electrode window 1808 c, the working electrode window 1808 d andthe additional electrode window 1808 e. The windows 1008 b-1808 e areeach defined through the outer surface 1802 c of the tube 1802, as shownin FIG. 84, and expose the respective electrode 740, 742, 744, 1820 tointerstitial fluid of the user when the proximalmost end 1802 a of thetube 1802 is inserted into the anatomy. The windows 1808 b-1808 e aredefined using laser cutting, for example. In this example, theelectrodes 740, 742, 744, 1820 are co-extruded with the tube 1802.During the extrusion process, the windows 1808 b-1808 e may also beemployed to segment the insulation over the electrodes 740, 742, 744,1820 to define the respective windows 1808 b-1808 e. For example, theextrusion may be paused to create gaps in the outer surface 1802 c. Theproximal end of the electrodes 740, 742, 744, 1820 may be exposed forconnecting to a communication component to communicate with the controlmodule 822, as discussed herein. A narrow strip 1803 of the tube 1802enables easy termination of the physiological characteristic sensor 1800and tube 1802, if desired.

In this example, the physiological characteristic sensor 1800 includesthe reference electrode 740, the counter electrode 742, the workingelectrode 744 and the additional electrode 1820. As discussed, thechemical reaction between the glucose and the oxygen at the workingelectrode 744 generates an electrical signal, which is transmitted bythe working electrode 744 and communicated to the control module 822 ofthe fluid infusion device 800, as will be discussed further herein. Itshould be noted that the counter electrode 742 does not necessarily haveto be coated. The reference electrode 740 does not have to be coatedeither, but is generally made of silver or silver-chloride. The workingelectrode 744 is coated with glucose oxidase and a glucose limitingmembrane above the glucose oxidase layer. The additional electrode 1820may be optional. If the additional electrode 1820 is present, theadditional electrode 1820 may be an additional working electrode, likethe working electrode 744, and the current from both working electrodes744, 1820 may be averaged by the control module 822. Alternatively, theadditional electrode 1820 may be an electrode coated with somethingother than glucose oxidase in order to detect other analytes of interest(other than glucose), which is transmitted to the control module 822 ofthe fluid infusion device 800. For example, the additional electrode1820 may measure ketone, lactate, etc. In addition, the additionalelectrode 1820 may measure insulin. The additional electrode 1820 mayalso be employed as a background electrode or may be used to observe adrug interference rejection.

In this example, in order to deploy the tube 1802 and the physiologicalcharacteristic sensor 1800, the infusion monitor unit 708 may bepre-packaged with an insertion instrument, such as the needle 1814. Theneedle 1814 surrounds the tube 1802, which includes the physiologicalcharacteristic sensor 1800. Once the infusion monitor unit 708 iscoupled to the anatomy, via the insertion instrument, the needle 1814can be retracted, leaving the physiological characteristic sensor 1800and the tube 1802 inserted into the anatomy.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 85, the tubecomprises a plurality of tubules or fibers 1850. Insofar as theplurality of fibers 1850 includes the same or similar components as thephysiological characteristic sensor 716 and the tube 706 discussed withregard to FIGS. 39-41, the physiological characteristic sensor 1000 andthe tube 1102 discussed with regard to FIGS. 45-47, and thephysiological characteristic sensor 1300 and the tube 1652 discussedwith regard to FIGS. 72-74, the same reference numerals will be used todenote the same or similar components.

The plurality of fibers 1850 may facilitate a fluidic connection betweena connector, like the connector 702, with the infusion monitor unit 708,and the plurality of fibers 1850 may extend from the housing 710 and beinserted into an anatomy of a user to enable delivering the fluid, suchas insulin, while also measuring a glucose level of the user. Theplurality of fibers 1850 are each hollow and are composed of a polymerbased material that is compatible to the fluid, including, but notlimited to polyether block amide, ethylene tetrafluoroethylene andpolytetrafluoroethylene. The fibers 1850 are generally extruded;however, other manufacturing techniques, such as additive manufacturing,may be employed. In this example, the fibers 1850 include seven fibers,however, any number of fibers may be employed to measure a blood glucoselevel of the user and to also dispense the fluid. In this example, threeof the fibers 1850 a-1850 c accommodate a respective one of thereference electrode 740, the counter electrode 742 and the workingelectrode 744 to define a physiological characteristic sensor 1852. Thefibers 1850 a-1850 c may be co-extruded with the electrodes 740, 742,744, or the electrodes 740, 742, 744 may be positioned within therespective fiber 1850 a-1850 c. Generally, the electrodes 740, 742, 744are insulated with a polymer, including, but not limited to polyetherblock amide, ethylene tetrafluoroethylene, polytetrafluoroethylene, etc.In some examples, the electrodes 740, 742, 744 and fibers 1850 a-1850 care compressed and joined at sidewalls through a heating process wherethe sidewalls reach a sufficient melt temperature for joining theelectrodes 740, 742, 744 to the fibers 1850 a-1850 c without collapsingthe fibers 1850 a-1850 c. In addition, although not shown herein, thefibers 1850 a-1850 c include windows, defined via laser cutting orthrough the extrusion process, to expose the electrodes 740, 742, 744 tothe interstitial fluid.

The remainder of the fibers 1850 d-1850 g dispense or deliver the fluidto the body of the user. At an inlet of the hollow fibers 1850 d-1850 g,the fibers 1850 d-1850 g are joined to a single source cavity thatadapts to an infusion set tube or tube that is connected to a connector,such as the connector 702 of FIG. 39. The connector is fluidly coupledto the fluid reservoir 160 such that the fluid reservoir 160 of thefluid infusion device 800 is a fluid source, which is fluidly connectedto the fibers 1850 d-1850 g. As the fluid travels from the tube fluidlyconnected to the fluid reservoir 160 to the inlet of the fibers 1850d-1850 g, the fluid distributes evenly between the fibers 1850 d-1850 gand exits from the end of the fibers 1850 d-1850 g into the tissue. Thequantity of fibers 1850 d-1850 g may vary based on the size of thefiber, needle and volume to dispense. In addition, while the fibers 1850a-1850 g are shown as having a circular cross-section, the fibers 1850a-1850 g may have any desired polygonal cross-section, such as oval,triangular, etc.

It should be noted that while the fibers 1850 a-1850 g are arranged toform a substantially circular shape, the fibers 1850 a-1850 g may bearranged to define any desired shape to fit within a needle 1860. Forexample, with reference to FIG. 86, the fibers 1850 a-1580 g arearranged to define an oval-shape. The arrangement of the fibers 1850a-1580 g in FIG. 86 enables the fibers 1850 a-1580 g to be positionedwithin a needle 1862, which is also similarly shaped.

In this example, in order to deploy the fibers 1850 a-1580 g, theinfusion monitor unit 708 may be pre-packaged with an insertioninstrument, such as the needle 1860, 1862. The needle 1860, 1862surrounds the fibers 1850 a-1580 g, which includes the electrodes 740,742, 744 to define the physiological characteristic sensor 1852. Oncethe infusion monitor unit 708 is coupled to the anatomy, via theinsertion instrument, the needle 1860, 1862 can be retracted, leavingthe fibers 1850 a-1580 g inserted into the anatomy.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 85, the tubecomprises a ribbon cable 1900. As the ribbon cable 1900 includes thesame or similar components as the physiological characteristic sensor716 and the tube 706 discussed with regard to FIGS. 39-41, thephysiological characteristic sensor 1000 and the tube 1102 discussedwith regard to FIGS. 45-47, and the physiological characteristic sensor1300 and the tube 1652 discussed with regard to FIGS. 72-74, the samereference numerals will be used to denote the same or similarcomponents.

The ribbon cable 1900 may facilitate a fluidic connection between aconnector, like the connector 702, with the infusion monitor unit 708,and the ribbon cable 1900 may extend from the housing 710 and beinserted into an anatomy of a user to enable delivering the fluid, suchas insulin, while also measuring a glucose level of the user. The ribboncable 1900 is composed of a polymer based material that is compatible tothe fluid, including, but not limited to polyether block amide, ethylenetetrafluoroethylene and polytetrafluoroethylene. The ribbon cable 1900is generally extruded; however, other manufacturing techniques, such asadditive manufacturing, may be employed. In this example, the ribboncable 1900 includes eight ribbons, however, any number of ribbons may beemployed to measure a blood glucose level of the user and to alsodispense the fluid. In this example, five of the ribbons 1900 a-1900 ereceive a respective one of the reference electrode 740, the counterelectrode 742, the working electrode 744 and two additional electrodes1904, 1906 to define a physiological characteristic sensor (e.g. glucosesensor) 1902, which is in communication with the control module 822. Theadditional electrodes 1904, 1906 may be optional. If the additionalelectrodes 1904, 1906 are included, the additional electrodes 1904, 1906may be an additional working electrode, like the working electrode 744,and the current from both working electrodes 744, 1904, 1906 may beaveraged by the control module 822. Alternatively, the additionalelectrodes 1904, 1906 may be an electrode coated with something otherthan glucose oxidase in order to detect other analytes of interest(other than glucose), which is transmitted to the control module 822.For example, the additional electrodes 1904, 1906 may measure ketone,lactate, etc. As a further alternative, the additional electrodes 1904,1906 may comprise counter electrodes, like the counter electrode 742. Inanother alternative, one of the two additional electrodes 1904, 1906 maycomprise a working electrode, like the working electrode 744, and theother of the two additional electrodes 1904, 1906 may comprise a counterelectrode, like the counter electrode 742, to provide redundancy andimprove response. In addition, the additional electrodes 1904, 1906 maymeasure insulin. The additional electrodes 1904, 1906 may also beemployed as a background electrode or may be used to observe a druginterference rejection.

The ribbon cable 1900 is in a first state in FIG. 87. The ribbons 1900a-1900 e may be co-extruded with the electrodes 740, 742, 744, 1904,1906 or the electrodes 740, 742, 744 may be positioned within therespective ribbons 1900 a-1900 e. Generally, the electrodes 740, 742,744, 1904, 1906 are insulated with a polymer, including, but not limitedto polyether block amide, ethylene tetrafluoroethylene,polytetrafluoroethylene, etc. In some examples, the electrodes 740, 742,744, 1904, 1906 and ribbons 1900 a-1900 e are compressed and joined atsidewalls through a heating process where the sidewalls reach asufficient melt temperature for joining the electrodes 740, 742, 744,1904, 1906 to the ribbons 1900 a-1900 e without collapsing the ribbons1900 a-1900 e. In addition, although not shown herein, the ribbons 1900a-1900 e include windows, defined via laser cutting, ablation, orthrough the extrusion process, to expose the electrodes 740, 742, 744 tothe interstitial fluid. The windows may be defined through the ribbons1900 a-1900 e at a location that is spaced apart from a terminal end ofthe ribbons 1900 to provide distance between the fluid dispensed and theelectrodes 740, 742, 744, 1904, 1906. The remainder of the ribbons 1900f-1900 h are filler or solid ribbons. It should be noted that while theribbon cable 1900 is shown with five electrodes, the ribbon cable 1900may have a lesser or greater number of electrodes depending upon therequirements of the physiological characteristic sensor 1902.

In order to dispense the fluid to the body of the user, the ribbon cable1900 is formed substantially into a circle in a second state to define aconduit 1901, as shown in FIG. 88. Ends 1908 a, 1908 b are coupledtogether to define the circle, via welding, adhesives, etc. An inlet ata proximal end of the ribbon cable 1900 receives the fluid from aninfusion set tube or tube that is connected to a connector, such as theconnector 702 of FIG. 39. The connector is fluidly coupled to the fluidreservoir 160 such that the fluid reservoir 160 of the fluid infusiondevice 800 is a fluid source, which is fluidly connected to the ribboncable 1900. The fluid reservoir 160 is fluidically coupled to the inletof ribbon cable 1900, and the ribbon cable 1900 dispenses the fluid fromthe fluid reservoir 160 at an outlet 1910. It should be noted that whilethe ribbon cable 1900 is arranged to form a substantially circularshape, the ribbon cable 1900 may be arranged to define any desired shapeto fit within a needle.

In this example, in order to deploy the ribbon cable 1900, the infusionmonitor unit 708 may be pre-packaged with an insertion instrument, whichincludes the needle. The needle partially envelopes or surrounds theribbon cable 1900 that includes the electrodes 740, 742, 744, 1904, 1906to define the physiological characteristic sensor 1902, or may bereceived through the conduit 1901. Once the infusion monitor unit 708 iscoupled to the anatomy, via the insertion instrument, the needle can beretracted, leaving the ribbon cable 1900 inserted into the anatomy.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 89, thephysiological characteristic sensor 1000 is shown integrally formed witha tube 1950 are shown. As the physiological characteristic sensor 1000and the tube 1950 include the same or similar components as thephysiological characteristic sensor 716 and the tube 706 discussed withregard to FIGS. 39-41, the physiological characteristic sensor 1000 andthe tube 1102 discussed with regard to FIGS. 45-47, and thephysiological characteristic sensor 1300 and the tube 1652 discussedwith regard to FIGS. 72-74, the same reference numerals will be used todenote the same or similar components.

The tube 1952 may facilitate a fluidic connection between a connector,like the connector 702, with the infusion monitor unit 708, and aproximalmost end 1952 a of the tube 1952 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 1952. The tube 1952 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded.

In some examples, the tube 1952 includes the reference electrode 740,the counter electrode 742 and the working electrode 744 co-extruded withthe tube 1952. The electrodes 740, 742, 744 are embedded into a sidewall1954 of the tube 1952 through the extrusion process, as shown in FIG.90. It should be noted number of embedded electrodes may vary dependingon the sensor design, and thus, the tube 1952 may include a lesser orgreater number of electrodes. A fluid delivery conduit 1956 is definedalong a center of the tube 1952, and receives the fluid from the fluidreservoir 160 and directs the fluid from the fluid reservoir 160 throughthe tube 1952. In this example, the fluid outlet 1962 is defined at theterminal end 1952 b to be spaced a distance apart from the physiologicalcharacteristic sensor 1000. By spacing the fluid outlet 1962 from thephysiological characteristic sensor 1000, the dispensing of the fluid ispositioned at a location within the anatomy that is different and spacedapart from a location at which the blood glucose level is beingmeasured, which may improve accuracy of the physiological characteristicsensor 1000.

It should be noted that co-extrusion of the electrodes 740, 742, 744with the tube 1952 is merely an example. With reference to FIG. 91, insome examples, the electrodes 740, 742, 744 are printed on the sidewall1954 of the tube 1952. The conductive inks and adhesives include, butare not limited to, gold, platinum, graphene, carbon, silver, etc.,which are printed on the tube 1952 in conjunction with the extrusionprocess. Generally, the electrodes 740, 742, 744 are printed along thelength of the tube 1952. After the electrodes 740, 742, 744 are printed,an insulation layer may be coated on top of the electrodes 740, 742, 744to control a location of a respective window that exposes the electrodes740, 742, 744 to the interstitial fluid. The coating may be done as anextrusion process, if desired.

With reference back to FIG. 89, the tube 1952 includes a plurality ofwindows 1958. The windows 1958 are each defined through the outersurface 1952 c of the tube 1952 and expose the respective electrode 740,742, 744 to interstitial fluid of the user when the proximalmost end1802 a of the tube 1802 is inserted into the anatomy. The windows 1958are defined using laser cutting or ablation, for example. In thisexample, the electrodes 740, 742, 744 are co-extruded with the tube1952. During the extrusion process, the windows 1958 may also beemployed to segment the insulation over the electrodes 740, 742, 744 todefine the respective windows 1958. For example, the extrusion may bepaused to create gaps in the outer surface 1952 c. The proximal end ofthe electrodes 740, 742, 744 are exposed to connect to the controlmodule 822.

In this example, the physiological characteristic sensor 1000 includesthe reference electrode 740, the counter electrode 742 and the workingelectrode 744. The chemical reaction between the glucose and the oxygenat the working electrode 744 generates an electrical signal, which istransmitted by the working electrode 744 and communicated to the controlmodule 822 of the fluid infusion device 800, as will be discussedfurther herein.

In this example, in order to deploy the tube 1952 and the physiologicalcharacteristic sensor 1000, the infusion monitor unit 708 may bepre-packaged with an insertion instrument, such as a needle. The needlemay partially surround the tube 1952 or may pass through the tube 1952,which includes the physiological characteristic sensor 1000. Once theinfusion monitor unit 708 is coupled to the anatomy, via the insertioninstrument, the needle can be retracted, leaving the physiologicalcharacteristic sensor 1000 and the tube 1952 inserted into the anatomy.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 92, thephysiological characteristic sensor 1300 is shown coupled to a tube2000. Insofar as the physiological characteristic sensor 1300 and thetube 2000 includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, the physiological characteristic sensor 1300 discussed withregard to FIGS. 53-55, and the physiological characteristic sensor 1300and the tube 1652 discussed with regard to FIGS. 72-74, the samereference numerals will be used to denote the same or similarcomponents.

The tube 2000 may facilitate a fluidic connection between a connector,like the connector 702, with the infusion monitor unit 708, and aproximalmost end 2000 a of the tube 2000 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 2000. The tube 2000 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc.

In this example, the physiological characteristic sensor 1300 ispositioned within the tube 2000 to extend outwardly away from a terminalend 2000 b of the tube 2000. In this example, the physiologicalcharacteristic sensor 1300 is centered within the tube 2000. Theterminal end 2000 b is a distance D2000 from the electrodes 1306, 1308,1310, and in some examples, the distance D2000 is about 10 millimeters(mm). A fluid outlet 2002 is defined at the terminal end 2000 b. Thefluid from the fluid reservoir 160 exits the tube 2000 at the fluidoutlet 2002 at the terminal end 2000 b. Thus, the fluid outlet 2002 isdefined at the terminal end 2000 b to be spaced a distance apart fromthe physiological characteristic sensor 1300. By spacing the fluidoutlet 2002 from the physiological characteristic sensor 1300, thedispensing of the fluid is positioned at a location within the anatomythat is different and spaced apart from a location at which the bloodglucose level is being measured, which may improve accuracy of thephysiological characteristic sensor 1300. In some examples, a proximalend of the physiological characteristic sensor 1300 is coupled to thetube 2000 within the infusion monitor unit 708 to secure thephysiological characteristic sensor 1300 relative to the tube 2000. Thephysiological characteristic sensor 1300 is free floating within thetube 2000 itself.

The physiological characteristic sensor 1300 includes the referenceelectrode 1306, the counter electrode 1308 and the working electrode1310. The chemical reaction between the glucose and the oxygen at theworking electrode 1310 generates an electrical signal, which istransmitted by the working electrode 1310 and communicated to thecontrol module 822 of the fluid infusion device 800, as will bediscussed further herein.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 93, thephysiological characteristic sensor 1300 is shown coupled to a tube2050. As the physiological characteristic sensor 1300 and the tube 2050includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, the physiological characteristic sensor 1300 discussed withregard to FIGS. 53-55, and the physiological characteristic sensor 1300and the tube 1652 discussed with regard to FIGS. 72-74, the samereference numerals will be used to denote the same or similarcomponents.

The tube 2050 may facilitate a fluidic connection between a connector,like the connector 702, with the infusion monitor unit 708, and aproximalmost end 2050 a of the tube 2050 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 2050. The tube 2050 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc.

In this example, the physiological characteristic sensor 1300 isintegrally formed with the tube 2050 to extend outwardly away from aside 2052 of the tube 2050 that includes a fluid outlet 2054. Thephysiological characteristic sensor 1300 may be integrally formed withthe tube 2050 by overmolding, printing, etc. The fluid outlet 2054 isthe distance D2000 from the electrodes 1306, 1308, 1310. The fluid fromthe fluid reservoir 160 exits the tube 2050 at the fluid outlet 2054.Thus, the fluid outlet 2054 is defined to be spaced a distance apartfrom the physiological characteristic sensor 1300. By spacing the fluidoutlet 2054 from the physiological characteristic sensor 1300, thedispensing of the fluid is positioned at a location within the anatomythat is different and spaced apart from a location at which the glucoselevel is being measured, which may improve accuracy of the physiologicalcharacteristic sensor 1300.

In this example, the physiological characteristic sensor 1300 includesthe reference electrode 1306, the counter electrode 1308 and the workingelectrode 1310. The chemical reaction between the glucose and the oxygenat the working electrode 1310 generates an electrical signal, which istransmitted by the working electrode 1310 and communicated to thecontrol module 822 of the fluid infusion device 800, as will bediscussed further herein.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 94, thephysiological characteristic sensor 1300 is shown coupled to a tube2100. As the physiological characteristic sensor 1300 and the tube 2100includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, the physiological characteristic sensor 1300 discussed withregard to FIGS. 53-55, and the physiological characteristic sensor 1300and the tube 2050 discussed with regard to FIG. 93, the same referencenumerals will be used to denote the same or similar components.

The tube 2100 may facilitate a fluidic connection between a connector,like the connector 702, and the infusion monitor unit 708, and aproximalmost end 2100 a of the tube 2100 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 2100. The tube 2100 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc.

In this example, with additional reference to FIG. 95, the physiologicalcharacteristic sensor 1300 is integrally formed with the tube 2100 toextend outwardly away from a side 2102 of the tube 2100 that is oppositea side 2104 of the tube 2100 that includes a fluid outlet 2106. Thephysiological characteristic sensor 1300 may be integrally formed withthe tube 2100 by overmolding, printing, etc. The fluid outlet 2106 isthe distance D2000 from the electrodes 1306, 1308, 1310. The fluid fromthe fluid reservoir 160 exits the tube 2100 at the fluid outlet 2106.Thus, the fluid outlet 2106 is defined to be spaced a distance apartfrom the physiological characteristic sensor 1300. By spacing the fluidoutlet 2106 from the physiological characteristic sensor 1300 and on theopposite side 2102, the dispensing of the fluid is positioned at alocation within the anatomy that is different and spaced apart from alocation at which the blood glucose level is being measured, which mayimprove accuracy of the physiological characteristic sensor 1300.

The physiological characteristic sensor 1300 includes the referenceelectrode 1306, the counter electrode 1308 and the working electrode1310. The chemical reaction between the glucose and the oxygen at theworking electrode 1310 generates an electrical signal, which istransmitted by the working electrode 1310 and communicated to thecontrol module 822 of the fluid infusion device 800, as will bediscussed further herein.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIGS. 96 and 97,the physiological characteristic sensor 1300 is shown coupled to a tube2150. As the physiological characteristic sensor 1300 and the tube 2150includes the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, the physiological characteristic sensor 1300 discussed withregard to FIGS. 53-55, and the physiological characteristic sensor 1300and the tube 2050 discussed with regard to FIG. 93, the same referencenumerals will be used to denote the same or similar components.

The tube 2150 may facilitate a fluidic connection between a connector,like the connector 702, and the infusion monitor unit 708, and aproximalmost end 2150 a of the tube 2150 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 2150. The tube 2150 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene, pellathane and may be extruded, molded, cast,additively manufactured, etc.

In this example, with reference to FIG. 98, the physiologicalcharacteristic sensor 1300 is integrally formed with the tube 2150 toextend outwardly away from a side 2152 of the tube 2150 that is oppositea side 2154 of the tube 2150 that includes at least one fluid outlet2156. The physiological characteristic sensor 1300 may be integrallyformed with the tube 2150 by overmolding, printing, etc. In thisexample, a fluid delivery conduit 2158 of the tube 2150 iscircumferentially closed, and the fluid from the fluid reservoir 160exits the tube 2150 at the at least one fluid outlet 2156. In thisexample, the at least one fluid outlet 2156 comprises two fluid outlets,however, the tube 2150 may include any number of fluid outlets 2156. Thefluid outlets 2156 are defined through a surface 2150 c of the tube 2150and are in fluid communication with the fluid delivery conduit 2158. Oneof the fluid outlets 2156 is at a distance D2150 from the electrodes1306, 1308, 1310, which in this example is about 15 millimeters (mm).Thus, the fluid outlets 2156 is defined to be spaced a distance apartfrom the physiological characteristic sensor 1300. By spacing the fluidoutlets 2156 from the physiological characteristic sensor 1300 and onthe opposite side 2152, the dispensing of the fluid is positioned at alocation within the anatomy that is different from a location at whichthe glucose level is being measured, which may improve accuracy of thephysiological characteristic sensor 1300.

The physiological characteristic sensor 1300 includes the referenceelectrode 1306, the counter electrode 1308 and the working electrode1310. The chemical reaction between the glucose and the oxygen at theworking electrode 1310 generates an electrical signal, which istransmitted by the working electrode 1310 and communicated to thecontrol module 822 of the fluid infusion device 800, as will bediscussed further herein.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 99, aphysiological characteristic sensor (e.g. glucose sensor) 2200 is showncoupled to a tube 2202. In the example of FIG. 99, four physiologicalcharacteristic sensors 2200 are shown coupled to one of a respectivefour tubes 2202. As the physiological characteristic sensor 2200 and thetube 2202 include the same or similar components as the physiologicalcharacteristic sensor 716 and the tube 706 discussed with regard toFIGS. 39-41, the physiological characteristic sensor 1300 discussed withregard to FIGS. 53-55, and the physiological characteristic sensor 1300and the tube 2050 discussed with regard to FIG. 93, the same referencenumerals will be used to denote the same or similar components. As eachof the physiological characteristic sensors 2200 and the tubes 2202 arethe same, a single one of the physiological characteristic sensors 2200and the tubes 2202 will be described herein.

The tube 2202 may facilitate a fluidic connection between a connector,like the connector 702, and the infusion monitor unit 708, and aproximalmost end 2202 a of the tube 2202 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 2202. The tube 2202 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene and pellathane. With reference to FIG. 100, the tube2202 has a rectangular cross-section. The tube 2202 may be supported ona support fixture 2204 during fabrication of the tube 2202 and thephysiological characteristic sensor 2200. In some examples, the tube2202 may be formed by extrusion, micro-electromechanicalsystem/photolithography, additively manufactured, etc. In the example ofmicro-electromechanical system/photolithography, the tube 2202 may bebuilt directly onto itself, layer by layer. The use of the rectangulartube 2202 enables the physiological characteristic sensor 2200 to beformed directly onto the tube 2202. In some examples, the referenceelectrode 2206, the counter electrode 2208 and the working electrode2210 of the physiological characteristic sensor 2200 are fabricated ontoa flat surface 2202 b of the tube 2202 through printing,screen-printing, laser etching, and/or photolithography. In addition, acoating, such as slot coating, spray coating, etc. may be used forchemistries associated with the working electrode 2210. The supportfixture 2204 is removed after the physiological characteristic sensor2200 is formed on the tube 2202. In this example, the fluid from thefluid reservoir 160 exits the tube 2202 at a fluid outlet 2212. In thisexample, the fluid outlet 2212 is defined at a terminal end 2202 c ofthe tube 2202.

In this example, the physiological characteristic sensor 2200 includesthe reference electrode 2206, the counter electrode 2208 and the workingelectrode 2210. As the reference electrode 2206, the counter electrode2208 and the working electrode 2210 are substantially the same as thereference electrode 1306, the counter electrode 1308 and the workingelectrode 1310 discussed previously herein, the reference electrode2206, the counter electrode 2208 and the working electrode 2210 will notbe discussed in detail. Briefly, the chemical reaction between theglucose and the oxygen at the working electrode 2210 generates anelectrical signal, which is transmitted by the working electrode 2210and communicated to the control module 822 of the fluid infusion device800, as will be discussed further herein.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIG. 101, aphysiological characteristic sensor (e.g. glucose sensor) 2250 is showncoupled to a tube 2252. As the physiological characteristic sensor 2200and the tube 2202 include the same or similar components as thephysiological characteristic sensor 716 and the tube 706 discussed withregard to FIGS. 39-41, the physiological characteristic sensor 1300discussed with regard to FIGS. 53-55, and the physiologicalcharacteristic sensor 2200 and the tube 2202 discussed with regard toFIGS. 99 and 100, the same reference numerals will be used to denote thesame or similar components.

The tube 2252 may facilitate a fluidic connection between a connector,like the connector 702, with the infusion monitor unit 708, and aproximalmost end 2252 a of the tube 2252 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 2252. The tube 2252 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP) ethylene tetrafluoroethyleneand pellathane. The tube 2252 is in a first state in FIG. 101. In thisexample, the tube 2252 is composed of three cannulated sections 2254,which are interconnected via a thin web section 2256. Each of thecannulated sections 2254 provide a fluid delivery conduit for the fluidfrom the fluid reservoir 160. In some examples, the cannulated sections2254 include at least one fluid outlet 2257 (FIG. 102), which is definedthrough a surface 2254 a of the respective cannulated section 2254. Thesurface 2254 a is opposite a surface 2254 b of the cannulated section2254 on which a portion of the physiological characteristic sensor 2250is formed to improve physiological characteristic sensor 2250 accuracy.In this example, the fluid from the fluid reservoir 160 exits the tube2252 at the fluid outlet 2257 associated with each of the cannulatedsections 2254. It should be noted that in other variations, a terminalend of each of the cannulated sections 2254 may define a fluid outlet.The thin web sections 2256 interconnect the three cannulated sections2254. Generally, the thin web sections 2256 form a living hinge, whichenables the cannulated sections 2254 to bend toward each other to definea circular structure or enclosure, as shown in FIG. 102. The tube 2252is in a second state in FIG. 102. It should be noted that while the tube2252 is shown in FIG. 102 as being formed such that the physiologicalcharacteristic sensor 2250 is on an external perimeter of the tube 2252while the fluid outlets 2257 are on an internal perimeter, the tube 2252may be formed such that the physiological characteristic sensor 2250 isalong the external perimeter of the tube 2252 and the fluid outlets 2257are on the internal perimeter.

With reference to FIG. 101, the cannulated sections 2254 have arectangular cross-section. In some examples, the tube 2252 may be formedby extrusion, micro-electromechanical system/photolithography,additively manufactured, etc. In the example of micro-electromechanicalsystem/photolithography, the tube 2252 may be built directly ontoitself, layer by layer. The use of the rectangular tube 2252 enables thephysiological characteristic sensor 2250 to be formed directly onto thetube 2252. A support fixture may be used to form the physiologicalcharacteristic sensor 2250 on the tube 2252. In some examples, areference electrode 2258, a counter electrode 2260 and a workingelectrode 2262 of the physiological characteristic sensor 2250 arefabricated onto a respective one of the surfaces 2254 b of thecannulated sections 2254 through printing, screen-printing, laseretching, and/or photolithography. In addition, a coating, such as slotcoating, spray coating, etc. may be used for chemistries associated withthe working electrode 2262.

In this example, the physiological characteristic sensor 2250 includesthe reference electrode 2258, the counter electrode 2260 and the workingelectrode 2262. As the reference electrode 2258, the counter electrode2260 and the working electrode 2262 are substantially the same as thereference electrode 1306, the counter electrode 1308 and the workingelectrode 1310 discussed previously herein, the reference electrode2258, the counter electrode 2260 and the working electrode 2262 will notbe discussed in detail. Briefly, the chemical reaction between theglucose and the oxygen at the working electrode 2262 generates anelectrical signal, which is transmitted by the working electrode 2262and communicated to the control module 822 of the fluid infusion device800, as will be discussed further herein.

It should be noted, however, that other sensor and tube configurationsare also contemplated. For example, with reference to FIGS. 103A and103B, a physiological characteristic sensor (e.g. glucose sensor) 2300is shown coupled to a tube 2302. Insofar as the physiologicalcharacteristic sensor 2300 and the tube 2302 include the same or similarcomponents as the physiological characteristic sensor 716 and the tube706 discussed with regard to FIGS. 39-41, the physiologicalcharacteristic sensor 1300 discussed with regard to FIGS. 53-55, and thephysiological characteristic sensor 2200 and the tube 2202 discussedwith regard to FIGS. 99 and 100, the same reference numerals will beused to denote the same or similar components.

The tube 2302 may facilitate a fluidic connection between a connector,like the connector 702, with the infusion monitor unit 708, and aproximalmost end 2302 a of the tube 2302 may extend from the housing 710and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin, while also measuring a glucose level of theuser. The connector is fluidly coupled to the fluid reservoir 160 suchthat the fluid reservoir 160 of the fluid infusion device 800 is a fluidsource, which is fluidly connected to the tube 2302. The tube 2302 maybe composed of a polymer based material, including, but not limited topolytetrafluroethylene (PTFE), polyethylene (PE), polyurethane (PU),Teflon coated catheters, polyether block amide (PEBA), Nylon, polyester,polyether ether ketone (PEEK), polyimide, polypropylene, perfluoroalkoxy(PFA), fluorinated ethylene propylene (FEP). The tube 2302 provides afluid delivery conduit for the fluid from the fluid reservoir 160. Insome examples, the tube 2302 includes one or more fluid outlets 2304. Inthis example, the tube 2302 includes a plurality of fluid outlets 2304,which increase in diameter from adjacent to a first, terminal end 2302 bof the tube 2302 toward a second end 2303 of the tube 2302. In thisexample, the tube 2302 includes four fluid outlets 2304 a-2304 d, whichare each defined through a surface 2302 c of the tube 2302. The surface2302 c is opposite a surface 2302 d of the tube 2302 coupled to thephysiological characteristic sensor 2300 to improve physiologicalcharacteristic sensor 2300 accuracy. The fluid outlets 2304 a-2304 d hasa respective diameter D23 a-D23 d, which as discussed, increasesmonotonically from the fluid outlet 2304 a to the fluid outlet 2304 d.The increasing diameters of the fluid outlets 2304 a-2304 d provides forpreferential fluid delivery. In the example of increasing diameters, thefluid is delivered in a larger quantity adjacent to a surface of theuser's skin where the fluid, such as insulin, is better absorbed by theinterstitial tissue. It should be noted, however, that the diameters D23a-D23 d may decrease monotonically, such that the fluid ispreferentially delivered closer to the terminal end 2302 b of the tube2302.

In some examples, the tube 2302 may be formed by extrusion,micro-electromechanical system/photolithography, additivelymanufactured, etc. In the example of micro-electromechanicalsystem/photolithography, the tube 2302 may have a rectangularcross-section as shown in FIGS. 103A and 103B. Alternatively, the tube2302 may be formed using extrusion, and may have a circularcross-section, as shown in FIGS. 104A and 104B.

The physiological characteristic sensor 2300 includes the referenceelectrode 1306, the counter electrode 1308 and the working electrode1310. The physiological characteristic sensor 2300 may be integrallyformed with the tube 2050 by overmolding, printing, screen-printing,laser etching, photolithography, etc. The chemical reaction between theglucose and the oxygen at the working electrode 1310 generates anelectrical signal, which is transmitted by the working electrode 1310and communicated to the control module 822 of the fluid infusion device800, as will be discussed further herein.

With reference to FIG. 105, the connector 702 is a removable reservoircap (or fitting) that is suitably sized and configured to accommodatereplacement of the fluid reservoir 160 (which are typically disposable)as needed. The needle 304 defines a flow path for the fluid out of thefluid reservoir 160, through the connector 702 and into the tube 706. Inthis example, the connector 702 is annular, and includes a first end2400 and an opposite second end 2402. The first end 2400 is fluidlycoupled to the second end 706 b of the tube 706, and may include agraspable surface 2400 a to enable a user to manipulate the connector702. With reference to FIG. 106, the second end 2402 iscircumferentially open, and defines a counterbore 2404 and a receptacle2406. The counterbore 2404 is sized and shaped to be positioned aboutthe fluid reservoir 160 to define the fluid flow path from the fluidreservoir 160 to the tube 706. The needle 304 extends through thecounterbore 2404, and is fluidly coupled to the first end 2400. Thereceptacle 2406 is defined along a side 2408 of the connector 702. Insome examples, the receptacle 2406 is rectangular, and is sized toextend from the second end 2402 toward the first end 2400. Thereceptacle 2406 receives a communication component 2410 associated withthe infusion monitor unit 708, which is removed from FIG. 106 forclarity.

With reference to FIG. 107, the connector 702 is sized to be receivedwithin a portion of a housing 802 of the fluid infusion device 800 suchthat the fluid flow path is defined between the fluid reservoir 160 andthe tube 706, and electrical communication is established between theinfusion monitor unit 708 and the fluid infusion device 800. Generally,the connector 702 establishes a fluidic connection between the tube 706and the fluid reservoir 160, and also establishes an electricalconnection between the physiological characteristic sensor 716 of theinfusion monitor unit 708 to communicate the glucose level to thecontrol module 822 of the fluid infusion device 800. It should be notedthat the following description of the connector 702 employed tofluidically and electrically connect the tube 706 and the physiologicalcharacteristic sensor 716 of the infusion monitor unit 708 with thecontrol module 822 of the fluid infusion device 800 is merely oneexample. In this regard, the connector 702 may be employed with any ofthe sensor and tube configurations for use with the infusion monitorunit 708 described herein with regard to FIGS. 39-104B. For example, theconnector 702 may be employed to fluidically connect or fluidly couplethe respective tube 706, 1002, 1102, 1202, 1249, 1301, 1402, 1449, 1502,1552, 1602, 1652, 1702, 1752, 1802, 1952, 2000, 2050, 2100, 2150 to thefluid reservoir 160 and to electrically connect or enable communicationbetween the respective physiological characteristic sensor 716, 1000,1300, 1800, 2200, 2250, 2300 and the control module 822. The connector702 may also be used to fluidically connect or fluidly couple theplurality of fibers 1850 to the fluid reservoir 160 and to electricallyconnect or enable communication between the plurality of fibers 1850 andthe control module 822. The connector 702 may also be used tofluidically and electrically connect the ribbon cable 1900 to the fluidreservoir 160 and the control module 822, respectively. In this example,the housing 802 of the fluid infusion device 800 includes a slot 2412 incommunication with the opening 410 to enable the connector 702 to bereceived within and coupled to the fluid infusion device 800.

With reference to FIG. 108, the connector 702 is shown exploded from thecommunication component 2410. In this example, the communicationcomponent 2410 is an antenna, including, but not limited to a near-fieldcommunication (NFC) antenna. The communication component 2410 transfersdata and power between the infusion monitor unit 708 and the fluidinfusion device 800. For example, the communication component 2410transfers data from the infusion monitor unit 708, such as observationsor measurements from the physiological characteristic sensor 716 to thefluid infusion device 800 (FIG. 39) and transfers power from the fluidinfusion device 800 to the infusion monitor unit 708 to provide power tothe physiological characteristic sensor 716 (FIG. 39). In alternativeembodiments, the communication component 2410 also transfers datawirelessly between the infusion monitor unit 708 and the fluid infusiondevice 800.

In this example, the communication component 2410 is defined by aplurality of trace coils 2410 a embedded into a flexible printed circuitboard 2410 b. The flexible printed circuit board 2410 b also includes aconnector 2413 that electrically and mechanically couples the electrodes740, 742, 744 to the communication component 2410. In this example, theconnector 2413 includes a plurality of contact pads 2413 a-2413 c,however, any suitable technique may be employed. As shown in FIG. 109,which is a detail view of the connector 2413 and the electrodes 740,742, 744 in isolation, the contact pads 2413 a-2413 c electrically andmechanically couple each of the electrodes 740, 742, 744 to thecommunication component 2410, which enables the communication component2410 to transmit both data and power to and from the electrodes 740,742, 744. Once coupled together, the contact pads 2413 a-2413 c and theelectrodes 740, 742, 744 may be covered with an electrical insulationcoating to inhibit electrical shorts. With reference to FIG. 110, thecommunication component 2410 may also include a control module 2415,which may be mechanically and electrically coupled to the printedcircuit board 2410 b to control the transfer of power and data by thecommunication component 2410 to a device communication component 2414.The control module 2415 may be located on either side of the printedcircuit board 2410 b, and may be coated with an electrical insulationlayer.

In this example, with reference to FIG. 111, the fluid infusion device800 includes a device communication component 2414. The devicecommunication component 2414 is in communication with the communicationcomponent 2410 to transfer data and power between the infusion monitorunit 708 and the fluid infusion device 800. In some examples, the devicecommunication component 2414 is an antenna, including, but not limitedto a near-field communication (NFC) antenna. The device communicationcomponent 2414 is electrically and mechanically coupled to the controlmodule 822 of the fluid infusion device 800, and in some examples, maybe formed of trace coils 2414 a on a portion of a printed circuit board2414 b associated with the control module 822. When the connector 702 iscoupled to the housing 802 of the fluid infusion device 800, as shown inFIG. 107, communication is established between the communicationcomponent 2410 and the device communication component 2414 due to theproximity of the communication component 2410 to the devicecommunication component 2414.

It should be noted, however, that while the communication component 2410and the device communication component 2414 are described herein asusing antennas to enable the transfer of data and power between theinfusion monitor unit 708 and the fluid infusion device 800, it shouldbe noted that the communication component 2410 and the devicecommunication component 2414 may be configured differently to enablecommunication between the infusion monitor unit 708 and the fluidinfusion device 800. For example, with reference to FIG. 112, acommunication component 2500 and a device communication component 2502are shown. As the communication component 2500 and the devicecommunication component 2502 include the same or similar components asthe communication component 2410 and the device communication component2414 discussed with regard to FIGS. 105-111, the same reference numeralswill be used to denote the same or similar components.

With reference to FIG. 113, the communication component 2500 is coupledto a receptacle 2506 defined in the connector 702. The receptacle 2506is defined along a side 2508 of the connector 702. In some examples, thereceptacle 2506 is rectangular, and is sized to extend from the secondend 2402 toward the first end 2400. In this example, the receptacle 2506includes a plurality of channels 2506 a-2506 c. The channels 2506 a-2506c expose a portion of the communication component 2500 to enablecommunication between the communication component 2500 and the devicecommunication component 2502. The channels 2506 a-2506 c are generallydefined to extend for a predefined length from proximate the second end2402 toward the first end 2400. With reference back to FIG. 112, theconnector 702 is sized to be received within a portion of the housing802 of the fluid infusion device 800 such that the fluid flow path isdefined between the fluid reservoir 160 and the tube 706, and electricalcommunication is established between the infusion monitor unit 708 andthe fluid infusion device 800. In this example, the housing 802 of thefluid infusion device 800 includes the slot 2412 in communication withthe opening 410 to enable the connector 702 to be received within andcoupled to the fluid infusion device 800.

With reference to FIG. 114, the connector 702 is shown exploded from thecommunication component 2500. In this example, the communicationcomponent 2500 includes a plurality of contact pads 2500 a-2500 c, onefor each of the electrodes 740, 742, 744. The communication component2500 transfers data and power between the infusion monitor unit 708 andthe fluid infusion device 800. For example, the communication component2500 transfers data from the infusion monitor unit 708, such asobservations or measurements from the physiological characteristicsensor 716, to the fluid infusion device 800 (FIG. 39) and transferspower from the fluid infusion device 800 to the infusion monitor unit708 to provide power to the physiological characteristic sensor 716(FIG. 39).

In this example, the communication component 2500 is defined by thecontact pads 2500 a-2500 c, which are embedded into a flexible printedcircuit board 2500 d. The flexible printed circuit board 2500 b alsoincludes the connector 2413 that electrically and mechanically couplesthe electrodes 740, 742, 744 to the communication component 2410. Asshown in FIG. 115, which is a detail view of the contact pads 2500a-2500 c, the connector 2413 and the electrodes 740, 742, 744 inisolation, the contact pads 2413 a-2413 c electrically and mechanicallycouple each of the electrodes 740, 742, 744 to a respective one of thecontact pads 2500 a-2500 c via the printed circuit board 2500 d, whichenables the communication component 2500 to transmit both data and powerto and from the electrodes 740, 742, 744. With reference to FIG. 116, inthis example, the communication component 2500 may also include thecontrol module 2415, which may be mechanically and electrically coupledto the printed circuit board 2500 d to control the transfer of power anddata by the communication component 2500 to the device communicationcomponent 2502. The control module 2415 may be located on either side ofthe printed circuit board 2500 d, and may be coated with an electricalinsulation layer. As shown in FIG. 116, each one of the channels 2506a-2506 c exposes a respective one of the contact pads 2500 a-2500 c whenthe communication component 2500 is coupled to the receptacle 2506. Theexposed portion of the contact pads 2500 a-2500 c enables communicationbetween the communication component 2500 and the device communicationcomponent 2502. In addition, the printed circuit board 2500 d is alsocoupled to the receptacle 2506 via heat stake, ultrasonic welding,adhesive, etc. to electrically isolate the contact pads 2500 a-2500 c inthe instance that the connector 702 is exposed to fluids.

In this example, with reference to FIG. 117, the device communicationcomponent 2502 is shown. The device communication component 2502 is incommunication with the communication component 2500 to transfer data andpower between the infusion monitor unit 708 and the fluid infusiondevice 800. In some examples, the device communication component 2502 isa pogo pin connector, with three pogo pins 2502 a-2502 c. Each pogo pin2502 a-2502 c is associated with a respective one of the contact pads2500 a-2500 c, and establishes electrical communication between theelectrodes 740, 742, 744 and the control module 822 of the fluidinfusion device 800. Each of the pogo pins 2502 a-2502 c extend adistance beyond a sidewall 2510 of the housing 802 to enable contactbetween the pogo pins 2502 a-2502 c and the contact pads 2500 a-2500 c.In this example, the sidewall 2510 defines a plurality of bores 2510a-2510 c, one for each of the pogo pins 2502 a-2502 c, however, thesidewall 2510 may be configured with a slot or other opening thatenables the pogo pins 2502 a-2502 c to make contact with the contactpads 2500 a-2500 c when the connector 702 is coupled to the housing 802.

In some examples, with reference to FIG. 118, the device communicationcomponent 2502 is shown in greater detail. The device communicationcomponent 2502 is electrically and mechanically coupled to the controlmodule 822 of the fluid infusion device 800 via a conductive wire 2514,and in some examples, includes the pogo pins 2502 a-2502 c, which arecoupled to a printed circuit board 2502 d. The printed circuit board2502 d is electrically and mechanically coupled to the control module822 via the conductive wire 2514, as shown in FIG. 119. In addition,with reference back to FIG. 117, the printed circuit board 2502 d isalso coupled to the sidewall 2510 via heat stake, ultrasonic welding,adhesive, etc. to form a seal that inhibits fluids from entering throughthe bores 2510 a-2510 c. Alternatively, or in addition, one or moresealing members, such as O-rings may be positioned about the pogo pins2502 a-2502 c to inhibit fluids from entering through the bores 2510a-2510 c. With reference to FIG. 120, when the connector 702 is coupledto the housing 802 of the fluid infusion device 800, communication isestablished between the communication component 2500 and the devicecommunication component 2502 due to the contact between the contact pads2500 a-2500 c and the pogo pins 2502 a-2502 c.

It should be noted, however, that the communication component 2500 maybe configured differently to enable communication with the devicecommunication component 2502. For example, with reference to FIG. 121, acommunication component 2550 is shown. The communication component 2550may be employed with the device communication component 2502 to enablecommunication between the infusion monitor unit 708 and the fluidinfusion device 800. As the communication component 2550 and the devicecommunication component 2502 include the same or similar components asthe communication component 2500 discussed with regard to FIGS. 112-120,the same reference numerals will be used to denote the same or similarcomponents.

With reference to FIG. 121, the communication component 2550 is coupledto a receptacle 2556 defined in the connector 702. The receptacle 2556is defined along a side 2558 of the connector 702. In some examples, thereceptacle 2556 is rectangular, and is sized to extend from the secondend 2402 toward the first end 2400. In this example, the receptacle 2556includes a plurality of channels 2556 a-2556 c and includes a gasket2560. The channels 2556 a-2556 c expose a portion of the communicationcomponent 2550 to enable communication between the communicationcomponent 2550 and the device communication component 2502. The channels2556 a-2556 c are generally defined to extend for a predefined lengthfrom proximate the second end 2402 toward the first end 2400, and insome examples, each of the channels 2556 a-2556 c include a ramp 2559.The ramp 2559 guides the respective one of the pogo pins 2502 a-2502 cinto the respective channel 2506 a-2506 c.

The gasket 2560 is compressible upon insertion of the connector 702 intothe housing 802 to form a watertight seal about the communicationcomponent 2550. The gasket 2560 may be composed of an elastomericmaterial. With reference to FIG. 122A, a side view of the connector 702with the communication component 2550 is shown. As shown, further inFIG. 122B, the gasket 2560 extends beyond a surface 2562 of theconnector 702 a distance D2560. The distance D2560 is predefined toenable the connector 702 to be inserted into the housing 802 (FIG. 119)of the fluid infusion device 800 without undue force. In this example,the gasket 2560 extends about a perimeter of the channels 2506 a-2506 c,however, the gasket 2560 may be configured to extend around each of thechannels 2506 a-2506 c individually, for example.

With reference back to FIG. 121, the communication component 2550includes the plurality of contact pads 2500 a-2500 c, one for each ofthe electrodes 740, 742, 744. The communication component 2550 transfersdata and power between the infusion monitor unit 708 and the fluidinfusion device 800. In this example, the communication component 2550is defined by the contact pads 2500 a-2500 c, which are embedded intothe flexible printed circuit board 2500 d. The communication component2500 may also include the control module 2415, which may be mechanicallyand electrically coupled to the printed circuit board 2500 d to controlthe transfer of power and data by the communication component 2500 tothe device communication component 2502. Each one of the channels 2556a-2556 c exposes a respective one of the contact pads 2500 a-2500 c whenthe communication component 2550 is coupled to the receptacle 2556. Theexposed portion of the contact pads 2500 a-2500 c enables communicationbetween the communication component 2550 and the device communicationcomponent 2502. In addition, the printed circuit board 2500 d is alsocoupled to the receptacle 2556 via heat stake, ultrasonic welding,adhesive, etc. to electrically isolate the contact pads 2500 a-2500 c inthe instance that the connector 702 is exposed to fluids. When theconnector 702 is coupled to the housing 802 of the fluid infusion device800 (FIG. 119), the gasket 2560 is compressed, and the ramps 2559 guidethe respective pogo pins 2502 a-2502 c into contact with the respectivecontact pad 2500 a-2500 c to establish communication between thecommunication component 2550 and the device communication component2502.

It should be noted, however, that while the communication component 2410and the device communication component 2414 are described herein asusing antennas to enable the transfer of data and power between theinfusion monitor unit 708 and the fluid infusion device 800, it shouldbe noted that the communication component 2410 and the devicecommunication component 2414 may be configured differently to enablecommunication between the infusion monitor unit 708 and the fluidinfusion device 800. For example, with reference to FIG. 123, acommunication component 2600 and a device communication component 2602are shown. As the communication component 2600 and the devicecommunication component 2602 include the same or similar components asthe communication component 2410 and the device communication component2414 discussed with regard to FIGS. 105-111 and the communicationcomponent 2500 and the device communication component 2502 discussedwith regard to FIGS. 112-120, the same reference numerals will be usedto denote the same or similar components.

With reference to FIG. 123, the communication component 2600 is coupledto a receptacle 2606 defined in the connector 702. The receptacle 2606is defined along a side 2608 of the connector 702. In some examples, thereceptacle 2606 is rectangular, and is sized to extend from the secondend 2402 toward the first end 2400. In this example, the receptacle 2606is rectangular. The connector 702 is sized to be received within aportion of the housing 802 of the fluid infusion device 800 such thatthe fluid flow path is defined between the fluid reservoir 160 and thetube 706, and electrical communication is established between theinfusion monitor unit 708 (FIG. 39) and the fluid infusion device 800.In this example, the housing 802 of the fluid infusion device 800includes the slot 2412 in communication with the opening 410 to enablethe connector 702 to be received within and coupled to the fluidinfusion device 800.

With reference to FIG. 124, the connector 702 and the communicationcomponent 2600 are partially exploded. In this example, thecommunication component 2600 includes an electrode connector 2610 and adevice connector 2612. The device connector 2612 is coupled to and inelectrical communication with the electrode connector 2610 and thedevice communication component 2602 (FIG. 123). With reference to FIG.125, the electrode connector 2610 is shown exploded from the connector702. The electrode connector 2610 includes a plurality of contact pads2610 a-2610 c, one for each of the electrodes 740, 742, 744. Thecommunication component 2600 transfers data and power between theinfusion monitor unit 708 and the fluid infusion device 800 (FIG. 39).For example, the communication component 2600 transfers data from theinfusion monitor unit 708, such as observations or measurements from thephysiological characteristic sensor 716, to the fluid infusion device800 (FIG. 39) and transfers power from the fluid infusion device 800 tothe infusion monitor unit 708 to provide power to the physiologicalcharacteristic sensor 716 (FIG. 39).

In this example, the communication component 2600 is defined by thecontact pads 2610 a-2610 c, which are embedded into a flexible printedcircuit board 2610 d. The flexible printed circuit board 2610 b alsoincludes the connector 2413 that electrically and mechanically couplesthe electrodes 740, 742, 744 to the communication component 2410. Inthis example, with reference to FIG. 126, the contact pads 2413 a-2413 celectrically and mechanically couple each of the electrodes 740, 742,744 to a respective one of the contact pads 2610 a-2610 c via theprinted circuit board 2610 d, which enables the communication component2500 to transmit both data and power to and from the electrodes 740,742, 744. With reference to FIG. 124, in this example, the communicationcomponent 2600 may also include the control module 2415, which may bemechanically and electrically coupled to the printed circuit board 2610d to control the transfer of power and data by the communicationcomponent 2600 to the device communication component 2602. The controlmodule 2415 may be located on either side of the printed circuit board2600 d, and may be coated with an electrical insulation layer. Inaddition, the printed circuit board 2610 d is also coupled to thereceptacle 2606 via heat stake, ultrasonic welding, adhesive, etc. toelectrically isolate the contact pads 2610 a-2610 c in the instance thatthe connector 702 is exposed to fluids.

The device connector 2612 is electrically and mechanically coupled tothe electrode connector 2610 and is received within the receptacle 2606.The device connector 2612 is compressible upon insertion of theconnector 702 into the housing 802 to form a watertight seal about thecommunication component 2600. The device connector 2612 may be composedof an elastomeric material. With reference to FIG. 127A, a side view ofthe connector 702 with the communication component 2600 is shown. Asshown, further in FIG. 127B, the device connector 2612 extends beyond asurface 2616 of the connector 702 a distance D2616. The distance D2616is predefined to enable the connector 702 to be inserted into thehousing 802 (FIG. 123) of the fluid infusion device 800 without undueforce. In this example, the device connector 2612 includes a pluralityof pins 2614 a-2614 c, which are associated with a respective one of thecontact pads 2610 a-2610 c. The pins 2614 a-1614 c are composed of anelectrically conductive material, including, but not limited to, carbon,and are coupled to a gasket 2615. The gasket 2615 is compressible by thehousing 802 (FIG. 123) to form the watertight seal between the connector702 and the housing 802. The gasket 2615 is composed of an electricallyinsulative material, including, but not limited to, silicone. Thecontact between the contact pads 2610 a-2610 c, the pins 2614 a-2614 cand the device communication component 2602 enable communication betweenthe infusion monitor unit 708 (FIG. 39) and the fluid infusion device800 (FIG. 39).

In this example, with reference to FIG. 128, the device communicationcomponent 2602 is shown. The device communication component 2602 is incommunication with the communication component 2600 to transfer data andpower between the infusion monitor unit 708 (FIG. 39) and the fluidinfusion device 800. In some examples, the device communicationcomponent 2602 is defined by contact pads 2620 a-2620 c, which areembedded into a flexible printed circuit board 2620 d. Each of thecontact pads 2620 a-2620 c is associated with a respective one of thepins 2614 a-2614 c, and establishes electrical communication between theelectrodes 740, 742, 744 and the control module 822 of the fluidinfusion device 800 (FIG. 123). Each of the contact pads 2620 a-2620 cextend along a sidewall 2630 of the housing 802 to enable contact by thepogo pins 2502 a-2502 c. In this example, the sidewall 2630 defines abore 2630 a, which is sized to receive the printed circuit board 2620 d.

In some examples, with reference to FIG. 129, the device communicationcomponent 2602 is shown in greater detail. The device communicationcomponent 2602 is electrically and mechanically coupled to the controlmodule 822 of the fluid infusion device 800 (FIG. 123) via a conductivewire 2634, and in some examples, includes the contact pads 2620 a-2620c, which are coupled to the printed circuit board 2620 d. The printedcircuit board 2620 d is electrically and mechanically coupled to thecontrol module 822 via the conductive wire 2634 (FIG. 123). Withreference back to FIG. 128, the printed circuit board 2620 d is alsocoupled to the sidewall 2630 via heat stake, ultrasonic welding,adhesive, etc. to form a seal that inhibits fluids from entering throughthe bore 2630 a. Alternatively, or in addition, one or more sealingmembers, such as O-rings may be positioned about the bore 2630 a toinhibit fluids from entering through the bore 2630 a. With reference toFIG. 123, when the connector 702 is coupled to the housing 802 of thefluid infusion device 800, communication is established between thecommunication component 2600 and the device communication component 2602due to the contact between the contact pads 2610 a-2610 c, the pins 2614a-2614 c and the contact pads 2620 a-2620 c.

Thus, with reference back to FIG. 39, the communication component 2410,2500, 2550, 2600 and the device communication component 2414, 2502, 2602enable communication between the infusion monitor unit 708 and the fluidinfusion device 800. In this example, the fluid infusion device 800 isdevoid of a user interface. As the fluid infusion device 800 issubstantially the same as the fluid infusion device 400 discussed withregard to FIGS. 11-26B except for the device communication component2414, 2502, 2602, the fluid infusion device 800 will not be discussed ingreat detail herein. Briefly, the fluid infusion device 800 includes thepower supply 420, the charging coil 424, 424′, the antenna 426, thecontrol module 822 and the drive system 110 that are accommodated in thepump chamber 412 a defined by a housing 802, and the fluid reservoirsystem 116 that is accommodated in a reservoir chamber 412 b defined bythe housing 802. As the housing 802 is substantially the same as thehousing 402 except for the device communication component 2414, 2502,2602 and the slot 2412, only the differences between the housing 802 andthe housing 802 will be discussed herein, with the understanding thatthe remainder of the housing 802 is the same as the housing 802. Thehousing 802 includes a first housing portion 804 and a second housingportion 806, which are coupled together to form the housing 802. Thefirst housing portion 804 and the second housing portion 806 are eachcomposed of a polymeric material, including, but not limited topolycarbonate, and may be molded, additively manufactured, etc. Briefly,the slot 2412 is defined in each of the first housing portion 804 andthe second housing portion 806 to be adjacent to and in communicationwith the opening 410. The slot 2412 cooperates with the opening 410 toreceive the connector 702. The housing 802 has the largest dimension andthe smallest dimension as discussed with regard to the housing 402.

The control module 822 includes a processor and a storage media that aremounted on a printed circuit board, but is also physically andelectrically coupled to the respective device communication component2414, 2502, 2602. In some embodiments, the printed circuit board is arigid printed circuit board that enables communication between the powersupply 420, drive system 110, the charging coil 424, 424′, the antenna426, the other components associated with the fluid infusion device 800and the control module 822. The control module 822 may be incommunication with the power supply 420 and drive system 110, and may bein communication with the charging coil 424, 424′ to supply power to thepower supply 420. The control module 822 may also be in communicationwith the antenna 426. The processor can be any custom made orcommercially available processor, a central processing unit (CPU), anauxiliary processor among several processors associated with the controlmodule 822, a semiconductor based microprocessor (in the form of amicrochip or chip set), a macroprocessor, any combination thereof, orgenerally any device for executing instructions. The computer readablestorage device or media may include volatile and nonvolatile storage inread-only memory (ROM), random-access memory (RAM), and keep-alivememory (KAM), for example. KAM is a persistent or non-volatile memorythat may be used to store various operating variables while theprocessor is powered down. The computer-readable storage device or mediamay be implemented using any of a number of known memory devices such asPROMs (programmable read-only memory), EPROMs (electrically PROM),EEPROMs (electrically erasable PROM), flash memory, or any otherelectrical, magnetic, and/or optical memory devices capable of storingdata, some of which represent executable instructions, used by thecontrol module 822 in controlling components associated with the fluidinfusion device 800 and the infusion monitor unit 708.

The instructions may include one or more separate programs, each ofwhich comprises an ordered listing of executable instructions forimplementing logical functions. The instructions, when executed by theprocessor, receive and process input signals, perform logic,calculations, methods and/or algorithms for controlling the componentsof the fluid infusion device 800, and generate signals to components ofthe fluid infusion device 800 to control the drive system 110 based onthe logic, calculations, methods, and/or algorithms Although only onecontrol module 822 is shown, embodiments of the fluid infusion device800 can include any number of control modules that communicate over anysuitable communication medium or a combination of communication mediumsand that cooperate to process signals received from the portableelectronic device, perform logic, calculations, methods, and/oralgorithms, and generate control signals to control features of thefluid infusion device 800. In various embodiments, one or moreinstructions of the control module 822, when executed by the processor,receive and process signals from the portable electronic deviceassociated with a user to generate one or more control signals to thepower supply 420 to supply power to the drive system 110, for example.The instructions, when executed by the processor, receive and processinput signals, perform logic, calculations, methods and/or algorithmsfor controlling the components of the infusion monitor unit 708, andgenerate signals to components of the infusion monitor unit 708 based onthe logic, calculations, methods, and/or algorithms. The instructions,when executed by the processor, receive and process input signalsreceived from the infusion monitor unit 708 and determine a glucoselevel or blood glucose value based on the signal received from theinfusion monitor unit 708. The communication between the infusionmonitor unit 708 and the fluid infusion device 800 enables the controlmodule 822 of the fluid infusion device 800 to monitor the blood glucoselevels of the user and in certain embodiments, may enable the controlmodule 822 of the fluid infusion device 800 to increase and/or decreasethe fluid supplied to the user via the infusion monitor unit 708 basedon the measured glucose levels. The fluid infusion device 800 may alsobe coupled to the patch plate 450, 460 via the coupling slot 414 definedin the housing 802, or one of the other techniques described with regardto coupling the fluid infusion device 400 to the patch plate 450, 460(e.g. magnetically, friction, mechanical fasteners). The fluid infusiondevice 800 may be charged via the charging mat 432 and/or the wirelesscharging dongle 434.

While the infusion set assembly 700 is described herein as usinginfusion monitor unit 708 to measure a blood glucose level of a user andto deliver a fluid to a user, it should be noted that the infusionmonitor unit 708 may be configured differently. For example, withreference to FIG. 130, a tube 2690 and an infusion monitor unit 2700 areshown. As the tube 2690 and the infusion monitor unit 2700 include thesame or similar components as the tube 706 and the infusion monitor unit708 discussed with regard to FIGS. 39-104B, the same reference numeralswill be used to denote the same or similar components.

With reference to FIG. 130, the tube 2690 includes a first end 2690 aand the opposite second end 706 b (FIG. 39). A first end 2690 a iscoupled to the infusion monitor unit 2700, while the second end iscoupled to a connector, such as the connector 702 (FIG. 39). In thisexample, a proximalmost end 2692 of the tube 2690 is inserted into theanatomy to provide the fluid flow path from the fluid reservoir 160(FIG. 39) into the anatomy of the user. The tube 2690 may facilitate afluidic connection between a connector, like the connector 702, and theinfusion monitor unit 2700, and the proximalmost end 2692 of the tube2690 may extend from a housing 2703 and be inserted into an anatomy of auser to enable delivering the fluid, such as insulin, while alsomeasuring a glucose level of the user. The connector is fluidly coupledto the fluid reservoir 160 such that the fluid reservoir 160 of thefluid infusion device 800 is a fluid source, which is fluidly connectedto the tube 2690. In some examples, with reference to FIG. 131, across-sectional view of the tube 2690 is shown. The tube 2690 includes aplurality of conduits 2694. In this example, the tube 2690 includes afluid delivery conduit 2694 a, a power electrode conduit 2694 b, aground electrode conduit 2694 c, a transmitter conduit 2694 d and areceiver conduit 2694 e. The fluid delivery conduit 2694 a receives thefluid from the fluid reservoir 160 and directs the fluid from the fluidreservoir 160 through the tube 2690. In some examples, with reference toFIG. 130, the fluid delivery conduit 2694 a terminates at theproximalmost end 2692 of the tube 2690, such that a fluid outlet isdefined at a terminal end of the proximalmost end 2692. With referenceto FIG. 131, the power electrode conduit 2694 b receives a power line2696 associated with the infusion monitor unit 2700, and directs thepower line 2696 through the tube 2690 to a unit control module 2702associated with the infusion monitor unit 2700. The ground electrodeconduit 2694 c receives a ground line 2697 associated with the infusionmonitor unit 2700, and directs the ground line 2697 through the tube2690 to the unit control module 2702 associated with the infusionmonitor unit 2700. The transmitter conduit 2694 d receives a transmitterline 2698 associated with the infusion monitor unit 2700, and directsthe transmitter line 2698 through the tube 2690 to the unit controlmodule 2702 associated with the infusion monitor unit 2700. The receiverconduit 2694 e receives a receiver line 2699 associated with theinfusion monitor unit 2700, and directs the receiver line 2699 throughthe tube 2690 to the unit control module 2702 associated with theinfusion monitor unit 2700. Thus, in this example, the proximalmost end2692 of the tube 2690 or the portion of the tube 2690 that extends intothe anatomy, includes merely the fluid delivery conduit 2694 a.

With reference back to FIG. 130, the infusion monitor unit 2700 is shownin greater detail. The infusion monitor unit 2700 includes the housing2703, the coupling member or adhesive patch 712 and a physiologicalcharacteristic sensor (e.g. glucose sensor) 2704. The housing 2703comprises the tube connector 720, the mount 722 and a unit controlmodule 2702. The tube connector 720 is coupled to the tube 706 and tothe mount 722. In this example, the first end 2690 a of the tube 2690passes through the housing 2703 so that the proximalmost end 2692 of thetube 2690 may be inserted into the anatomy. The tube 2690 can be coupledto the tube connector 720 through any suitable technique, including, butnot limited to, press-fit, adhesives, welding, etc. The first end 2690 aof the tube 2690 is mechanically and electrically coupled to the unitcontrol module 2702 to enable communication between the unit controlmodule 2702 and the lines 2696-2699. The adhesive patch 712 is affixesthe infusion monitor unit 2700 to an anatomy, such as the skin of theuser. Thus, the infusion monitor unit 2700 includes the housing 2703that is configured to be adhesively coupled to an anatomy of a user. Inthis example, the physiological characteristic sensor 2704 is coupled tothe tube 2690, but is not integral with the tube 2690 such that the tube2690 delivers the fluid from the fluid reservoir 160 to the anatomy ofthe user, while the separate glucose sensor 2704 measures a level ofblood glucose within the anatomy of the user. It should be noted thatthe glucose sensor 2704 is not limited to a glucose sensor, but rather,various other physiological characteristic sensors may be employed.Further, it should be noted that the glucose sensor 2704 and the tube2690 may be integrally formed, as discussed previously herein withregard to FIGS. 39-104B, if desired. The physiological characteristicsensor 2704 is an electrochemical sensor that includes the glucoseoxidase enzyme, as is well understood by those familiar with glucosesensor technology. The glucose oxidase enzyme enables the physiologicalcharacteristic sensor 2704 to monitor blood glucose levels in a diabeticpatient or user by effecting a reaction of glucose and oxygen. Again,although certain embodiments pertain to glucose sensors, the technologydescribed here can be adapted for use with any one of the wide varietyof sensors known in the art. In this example, the physiologicalcharacteristic sensor 2704 is positionable in subcutaneous tissue of theuser by the same insertion instrument that inserts the proximalmost end2692 of the tube 2690 into the anatomy to measure the glucose oxidaseenzyme.

In this example, with reference to FIG. 132, FIG. 132 is a schematiccircuit diagram of the infusion monitor unit 2700. In this example, thephysiological characteristic sensor 2704 includes the referenceelectrode 740, the counter electrode 742 and the working electrode 744.As is generally known, the working electrode 744 is coated with theglucose oxidase enzyme. The reference electrode 740 maintains a constantvoltage to support the chemical reaction at the working electrode 744.The counter electrode 742 supplies current to maintain the set potentialon the working electrode 744. The electrodes are powered and sensed bythe unit control module 2702 via the power line 2696. When glucose andoxygen diffuse to the glucose oxidase layer, hydrogen peroxide isformed. Hydrogen peroxide present at the working electrode 744metallization layer breaks down and generates electrons when a voltageis applied at to the working electrode 744. These electrons generates anelectrical signal, which is transmitted by the working electrode 744 tothe unit control module 2702. The unit control module 2702 processes theelectrical signal, and determines the glucose level of the user, whichis transmitted as a digital signal to a control module associated with afluid infusion device, such as the control module 822 of the fluidinfusion device 800, via the transmitter line 2698. Thus, in thisexample, the infusion monitor unit 2700 determines the blood glucoselevel of the user at the infusion monitor unit 2700 via the unit controlmodule 2702 and transmits this value to the control module 822 of thefluid infusion device 800.

With reference to FIG. 133, the infusion monitor unit 2700 is shown witha portion of the housing 2703 removed. As shown, in some examples, theunit control module 2702 includes a printed circuit board 2710, a firstmodule 2712 and a second module 2714. The printed circuit board 2710physically and electrically couples the lines 2696-2699 to the firstmodule 2712, physically and electrically couples the electrodes 740,742, 744 to the second module 2714 and enables communication between thefirst module 2712 and the second module 2714. The first module 2712 isin communication with the lines 2696-2699 and the second module 2714 viathe printed circuit board 2710. The second module 2714 is incommunication with the electrodes 740, 742, 744 and the first module2712 via the printed circuit board 2710. Each of the first module 2712and the second module 2714 includes at least one processor and acomputer readable storage device or media, which are mounted to theprinted circuit board 2710. The processor can be any custom made orcommercially available processor, a central processing unit (CPU), anauxiliary processor among several processors associated with the firstmodule 2712 and the second module 2714, a semiconductor basedmicroprocessor (in the form of a microchip or chip set), amacroprocessor, any combination thereof, or generally any device forexecuting instructions. The computer readable storage device or mediamay include volatile and nonvolatile storage in read-only memory (ROM),random-access memory (RAM), and keep-alive memory (KAM), for example.KAM is a persistent or non-volatile memory that may be used to storevarious operating variables while the processor is powered down. Thecomputer-readable storage device or media may be implemented using anyof a number of known memory devices such as PROMs (programmableread-only memory), EPROMs (electrically PROM), EEPROMs (electricallyerasable PROM), flash memory, or any other electrical, magnetic, and/oroptical memory devices capable of storing data, some of which representexecutable instructions, used by the first module 2712 and the secondmodule 2714 in controlling components associated with the infusionmonitor unit 2700.

The instructions may include one or more separate programs, each ofwhich comprises an ordered listing of executable instructions forimplementing logical functions. The instructions, when executed by theprocessor, receive and process input signals, perform logic,calculations, methods and/or algorithms for controlling the componentsof the glucose sensor 2704, and generate signals to components of thefluid infusion device 800 of the measured/observed blood glucose levelbased on the logic, calculations, methods, and/or algorithms. Althoughtwo modules 2712, 2714 are shown, embodiments of the infusion monitorunit 2700 can include any number of control modules that communicateover any suitable communication medium or a combination of communicationmediums and that cooperate to process signals received from the lines2696, 2697, 2698, 2699 and the electrodes 740, 742, 744, perform logic,calculations, methods, and/or algorithms, and generate signals fortransmission to the control module 822 of the fluid infusion device 800.In various embodiments, one or more instructions of the first module2712, when executed by the processor, receive and process signals fromthe lines 2696, 2697, 2698, 2699 and the second module 2714 to enablecommunication between the infusion monitor unit 2700 and the controlmodule 822 of the fluid infusion device 800. In various embodiments, oneor more instructions of the second module 2714, when executed by theprocessor, receive and process signals from the electrodes 740, 742, 744and the first module 2712 to determine the blood glucose level of theuser. Thus, the infusion monitor unit 2700 determines the blood glucoselevel at the infusion monitor unit 2700 and communicates the bloodglucose level value to the control module 822 of the fluid infusiondevice 800 via the tube 2690.

While the infusion set assembly 700 is described herein as usinginfusion monitor unit 708 to measure a blood glucose level of a user andto deliver a fluid to a user, it should be noted that the infusionmonitor unit 708 may be configured differently. For example, withreference to FIG. 134, an infusion monitor unit 2750 is shown. As theinfusion monitor unit 2750 includes the same or similar components asthe infusion set assembly 300 discussed with regard to FIGS. 11-26B, theinfusion monitor unit 708 discussed with regard to FIGS. 39-104B and theinfusion monitor unit 2700 discussed with regard to FIGS. 130-133, thesame reference numerals will be used to denote the same or similarcomponents.

With reference to FIG. 134, the infusion monitor unit 2750 is fluidlycoupled via a tube 2751 to a connector, like the connector 302 (FIG.11). Thus, in this example, the tube 2751 is devoid of the conduits forelectrodes, and only includes a central conduit that defines the fluidflow path for the fluid from the fluid reservoir 160 (FIG. 11) to theinfusion monitor unit 2750. A first end 2751 a is coupled to theinfusion monitor unit 2750, while the second end is coupled to aconnector, such as the connector 302 (FIG. 11). In this example, aproximalmost end 2751 b of the tube 2751 is inserted into the anatomy toprovide the fluid flow path from the fluid reservoir 160 (FIG. 39) intothe anatomy of the user. The tube 2751 may facilitate a fluidicconnection between a connector, like the connector 302, and the infusionmonitor unit 2700, and the proximalmost end 2751 b of the tube 2751 mayextend from a housing 2703 and be inserted into an anatomy of a user toenable delivering the fluid, such as insulin, while also measuring aglucose level of the user. The connector is fluidly coupled to the fluidreservoir 160 such that the fluid reservoir 160 of the fluid infusiondevice 400 is a fluid source, which is fluidly connected to the tube2751. The proximalmost end 2751 b of the tube 306 is inserted into theanatomy, and a fluid outlet is defined at a terminal end of theproximalmost end 2751 b. The infusion monitor unit 2750 includes thehousing 2703, the coupling member or adhesive patch 712, thephysiological characteristic sensor (glucose sensor) 2704 and a unitcontrol module 2752. In this example, the tube 2751 is coupled to andpasses through the housing 2703 so that the proximalmost end 2751 b ofthe tube 2751 may be inserted into the anatomy. The adhesive patch 712is affixes the infusion monitor unit 2750 to an anatomy, such as theskin of the user. Thus, the infusion monitor unit 2750 includes thehousing 2703 that is configured to be adhesively coupled to an anatomyof a user.

In this example, the physiological characteristic sensor 2704 is coupledto the tube 2751, but is not integrally formed with the tube 2751. Thetube 2751 delivers the fluid from the fluid reservoir 160 and theglucose sensor 2704 measures a glucose level within the anatomy of theuser. It should be noted that the physiological characteristic sensor2704 is not limited to a glucose sensor, but rather, various otherphysiological characteristic sensors may be employed. Further, it shouldbe noted that the physiological characteristic sensor 2704 and the tube2751 may be integrally formed, as discussed previously herein withreference to FIGS. 39-104B, if desired. The physiological characteristicsensor 2704 is an electrochemical sensor that includes the glucoseoxidase enzyme, as is well understood by those familiar with glucosesensor technology. The glucose oxidase enzyme enables the physiologicalcharacteristic sensor 2704 to monitor blood glucose levels in a diabeticpatient or user by effecting a reaction of glucose and oxygen. Again,although certain embodiments pertain to glucose sensors, the technologydescribed here can be adapted for use with any one of the wide varietyof sensors known in the art. In this example, the physiologicalcharacteristic sensor 2704 is positionable in subcutaneous tissue of theuser by the same insertion instrument that inserts the proximalmost end2751 b of the tube 2751 into the anatomy to measure the glucose oxidaseenzyme.

In this example, with reference to FIG. 135, the infusion monitor unit2750 is shown with a portion of the housing 2703 removed. As shown, insome examples, the unit control module 2752 includes a circuit board2760, a first module 2762, a power source 2764, a communicationcomponent 2766 and the second module 2714. In this example, the infusionmonitor unit 2750 determines the blood glucose level of the user at theinfusion monitor unit 2750 via the unit control module 2752 andtransmits this value to the control module 422 of the fluid infusiondevice 400 via the communication component 2766, which may improveaccuracy of the blood glucose level value.

The printed circuit board 2710 physically and electrically couples theelectrodes 740, 742, 744 to the second module 2714 and enablescommunication between the first module 2762, the second module 2714, thepower source 2764 and the communication component 2766. The first module2762 is in communication with the power source 2764, the communicationcomponent 2766 and the second module 2714 via the printed circuit board2760. The first module 2762 includes at least one processor and acomputer readable storage device or media, which are mounted to theprinted circuit board 2760. The processor can be any custom made orcommercially available processor, a central processing unit (CPU), anauxiliary processor among several processors associated with the firstmodule 2762, a semiconductor based microprocessor (in the form of amicrochip or chip set), a macroprocessor, any combination thereof, orgenerally any device for executing instructions. The computer readablestorage device or media may include volatile and nonvolatile storage inread-only memory (ROM), random-access memory (RAM), and keep-alivememory (KAM), for example. KAM is a persistent or non-volatile memorythat may be used to store various operating variables while theprocessor is powered down. The computer-readable storage device or mediamay be implemented using any of a number of known memory devices such asPROMs (programmable read-only memory), EPROMs (electrically PROM),EEPROMs (electrically erasable PROM), flash memory, or any otherelectrical, magnetic, and/or optical memory devices capable of storingdata, some of which represent executable instructions, used by the firstmodule 2762 in controlling components associated with the infusionmonitor unit 2750.

The instructions may include one or more separate programs, each ofwhich comprises an ordered listing of executable instructions forimplementing logical functions. The instructions, when executed by theprocessor, receive and process input signals, perform logic,calculations, methods and/or algorithms for controlling the componentsof the glucose sensor 2704, and generate signals to be transmitted viathe communication component 2766 to the antenna 426 of the fluidinfusion device 400 of the measured/observed blood glucose level basedon the logic, calculations, methods, and/or algorithms Although twomodules 2762, 2714 are shown, embodiments of the infusion monitor unit2750 can include any number of control modules that communicate over anysuitable communication medium or a combination of communication mediumsand that cooperate to process signals received from the electrodes 740,742, 744, perform logic, calculations, methods, and/or algorithms, andgenerate signals for transmission to the fluid infusion device 400. Invarious embodiments, one or more instructions of the first module 2762,when executed by the processor, receive and process signals from thesecond module 2714 and transmit the signals from the second module 2714via the communication component 2766 to the antenna 426 of the fluidinfusion device 400 to enable communication between the infusion monitorunit 2750 and the fluid infusion device 400 (FIG. 11). In variousembodiments, one or more instructions of the second module 2714, whenexecuted by the processor, receive and process signals from theelectrodes 740, 742, 744 to determine the blood glucose level of theuser.

The power source 2764 supplies power to the first module 2762 and thesecond module 2714. The power source 2764 is any suitable supply ofpower, including, but not limited to a coin-cell battery, etc. The firstmodule 2762 supplies the power to the communication component 2766 totransmit the measured blood glucose level value to the fluid infusiondevice 400 (FIG. 11). The second module 2714 supplies the power from thepower source 2764 to the electrodes 740, 742, 744 to measure the bloodglucose level of the user.

The communication component 2766 enables communication between theantenna 426 of the fluid infusion device 400 and the infusion monitorunit 2750. Thus, generally, the communication component 2766 cooperateswith the antenna 426 to enable wireless communication between theinfusion monitor unit 2750 and the fluid infusion device 400. In someexamples, the infusion monitor unit 2750 communication component 2766may include, but is not limited to, near-field communication (NFC)antenna, a radio frequency (RF) communication antenna, a far-fieldcommunication antenna, a wireless communication system configured tocommunicate via a wireless local area network (WLAN) using Institute ofElectrical and Electronics Engineers (IEEE) 802.11 standards or by usingcellular data communication, a BLUETOOTH antenna, etc. In certainembodiments, the communication component 2766 of the infusion monitorunit 2750 may include more than one communication device, such as a nearfield communication (NFC) antenna and a BLUETOOTH low energy (BLE) traceantenna. Thus, the infusion monitor unit 2750 determines the bloodglucose level at the infusion monitor unit 2750 and communicates theblood glucose level value wirelessly to the control module 422 of thefluid infusion device 400 via the communication component 2766 and theantenna 426.

While the infusion set assembly 700 is described herein as usinginfusion monitor unit 708 to measure a blood glucose level of a user andto deliver a fluid to a user, it should be noted that the infusionmonitor unit 708 may be configured differently. For example, withreference to FIG. 136, an infusion monitor unit 2800 is shown. As theinfusion monitor unit 2800 includes the same or similar components asthe infusion set assembly 300 discussed with regard to FIGS. 11-26B, theinfusion monitor unit 708 discussed with regard to FIGS. 39-104B and theinfusion monitor unit 2700 discussed with regard to FIGS. 130-133, thesame reference numerals will be used to denote the same or similarcomponents.

With reference to FIG. 136, the infusion monitor unit 2800 is fluidlycoupled to a tube to define the fluid flow path for the fluid from thefluid reservoir 160 (FIG. 11) to the infusion monitor unit 2800. In thisexample, the infusion monitor unit 2800 includes a housing 2802, thecoupling member or adhesive patch 712, a delivery cannula 2804, aphysiological characteristic or glucose sensor 2806 and the unit controlmodule 2752. In FIG. 136, the infusion monitor unit 2800 is showncontained within an insertion instrument or needle 2801. The housing2802 is composed of a polymeric material, and encloses the unit controlmodule 2752. The housing 2802 may include one or more inlet ports forcoupling to a tube to supply the fluid to the infusion monitor unit2800. The housing 2802 may also include an opening for receiving theinsertion needle 2801 through the housing 2802. This opening may becovered by a septum, for example. The adhesive patch 712 is affixes theinfusion monitor unit 2800 to an anatomy, such as the skin of the user.Thus, the infusion monitor unit 2800 includes the housing 2802 that isconfigured to be adhesively coupled to an anatomy of a user.

In this example, with reference to FIG. 137, the delivery cannula 2804is shown in greater detail. The delivery cannula 2804 includes a fluidconduit 2810 and a shape conduit 2812. The fluid conduit 2810 is fluidlycoupled to the tube to define the fluid flow path from the fluidreservoir 160 (FIG. 11) to the anatomy. The tube may facilitate afluidic connection between a connector, like the connector 302, and theinfusion monitor unit 2800, and delivery cannula 2804 may extend fromthe housing 2802 and be inserted into an anatomy of a user to enabledelivering the fluid, such as insulin, while also measuring a glucoselevel of the user. The connector is fluidly coupled to the fluidreservoir 160 such that the fluid reservoir 160 of the fluid infusiondevice 400 is a fluid source, which is fluidly connected to the fluidconduit 2810. The shape conduit 2812 receives a shape-memory wire 2814,such as a nitinol wire or ribbon. The shape-memory wire 2814 isconfigured to move the delivery cannula 2804 between a first state,shown in FIG. 136, and a second state, shown in FIG. 138. By moving tothe second state, with reference to FIG. 138, the shape-memory wire 2814creates a distance D2800 between the delivery cannula 2804 and theglucose sensor 2806, which may improve the accuracy of the glucosesensor 2806. Generally, the shape-memory wire 2814 has a radius ofcurvature, which is opposite a radius of curvature of a shape-memorywire 2816 associated with the glucose sensor 2806 such that in thesecond state, the delivery cannula 2804 is curved away from the glucosesensor 2806. Thus, in the first state the glucose sensor 2806 isproximate the delivery cannula 2804, and in the second state, theglucose sensor 2806 is spaced apart from the delivery cannula 2804. Inthe first state, the delivery cannula 2804 and the glucose sensor 2806are contained within the insertion needle 2801, and in the second state,the insertion needle 2801 is retracted or removed from the infusionmonitor unit 2800.

With reference to FIG. 139, the glucose sensor 2806 includes theshape-memory wire 2816, a substrate 2818 and a glucose sensor electrode2820. The shape-memory wire 2816 comprises a nitinol wire or ribbon. Theshape-memory wire 2816 is configured to move the glucose sensor 2806between a first state, shown in FIG. 136, and a second state, shown inFIG. 138. With continued reference to FIG. 139, the substrate 2818 iscomposed of a polymeric material, such as a polyimide, and encases theshape-memory wire 2816. The glucose sensor electrode 2820 is coupled tothe substrate 2818. The glucose sensor electrode 2820 is coated with aglucose sensor chemistry layer 2822, and is configured to determine ablood glucose level associated with the user, as is generally known. Itshould be noted that a top surface of the glucose sensor electrode 2820may flush with a top surface of the substrate 2818. Alternatively, thetop surface of the electrode 2820 may be set below the top surface ofthe substrate 2818. It should be noted that in other configurations, theglucose sensor electrode 2820 may face away from the shape-memory wire2816 in order to not be shadowed by the shape-memory wire 2816. Inanother configuration, the shape-memory wire 2816 may be a counter orreference electrode through platinization of the shape-memory wire 2816.

The unit control module 2752 includes the circuit board 2760, the firstmodule 2762, the power source 2764, the communication component 2766 andthe second module 2714. In this example, the infusion monitor unit 2800determines the blood glucose level of the user at the infusion monitorunit 2800 via the unit control module 2752 and transmits this value tothe control module 422 of the fluid infusion device 400 via thecommunication component 2766 and the antenna 426, which may improveaccuracy of the blood glucose level value.

While the infusion set assembly 700 is described herein as usinginfusion monitor unit 708 to measure a blood glucose level of a user andto deliver a fluid to a user, it should be noted that the infusionmonitor unit 708 may be configured differently. For example, withreference to FIG. 140, an infusion monitor unit 2850 is shown. As theinfusion monitor unit 2850 includes the same or similar components asthe infusion set assembly 300 discussed with regard to FIGS. 11-26B, thephysiological characteristic sensor 1300 discussed with regard to FIGS.53-55, the infusion monitor unit 2700 discussed with regard to FIGS.130-133 and the infusion monitor unit 2800 discussed with regard toFIGS. 136-139, the same reference numerals will be used to denote thesame or similar components.

With reference to FIG. 140, the infusion monitor unit 2850 is fluidlycoupled to a tube to define the fluid flow path for the fluid from thefluid reservoir 160 (FIG. 11) to the infusion monitor unit 2850. In thisexample, the infusion monitor unit 2850 includes a housing 2852, thecoupling member or adhesive patch 712, a delivery cannula 2854, thephysiological characteristic sensor 1300 and the unit control module2752. The housing 2852 is composed of a polymeric material, and enclosesthe unit control module 2752. The housing 2852 is generally rectangular.The housing 2802 may include one or more inlet ports for coupling to atube to supply the fluid to the infusion monitor unit 2850. The housing2802 may also include an opening for receiving the insertion needle 2801through the housing 2802. This opening may be covered by a septum, forexample. In this example, the housing 2852 includes a first housingportion 2856 and a second housing portion 2858. The first housingportion 2856 is coupled to the second housing portion 2858 via welding,such as ultrasonic welding, radiofrequency welding, etc., about aperimeter of the first housing portion 2856 and the second housingportion 2858 to inhibit fluid flow into the housing 2852. The interiorof the first housing portion 2856 and the second housing portion 2858may also include posts 2860, which may be welded together, viaultrasonic welding, radiofrequency welding, etc., to further couple thefirst housing portion 2856 to the second housing portion 2858 whileinhibiting fluid flow into the housing 2852. One or more sealing members2862, such as O-rings, may be positioned between the first housingportion 2856 and the second housing portion 2858 and may be compressibleupon assembly of the first housing portion 2856 to the second housingportion 2858 to further inhibit the flow of fluid into the housing 2852.Generally, one sealing member 2862 may be coupled to the first housingportion 2856 and one sealing member 2862 may be coupled to the secondhousing portion 2858, with each of the sealing members 2862 coupledabout the delivery cannula 2854 and the physiological characteristicsensor 1300 to inhibit fluid from flowing into the housing 2852. Theadhesive patch 712 is affixes the infusion monitor unit 2850 to ananatomy, such as the skin of the user.

In this example, with reference to FIG. 140, the delivery cannula 2854is shown in greater detail. The delivery cannula 2854 is fluidly coupledto the tube to define the fluid flow path from the fluid reservoir 160(FIG. 11) to the anatomy. The delivery cannula 2854 is fluidly coupledto the tube to define the fluid flow path from the fluid reservoir 160(FIG. 11) to the anatomy. The tube may facilitate a fluidic connectionbetween a connector, like the connector 302, and the infusion monitorunit 2850, and the delivery cannula 2854 may extend from the housing2852 and be inserted into an anatomy of a user to enable delivering thefluid, such as insulin. The connector is fluidly coupled to the fluidreservoir 160 such that the fluid reservoir 160 of the fluid infusiondevice 400 is a fluid source, which is fluidly connected to the deliverycannula 2854. The delivery cannula 2854 is inserted into the anatomy todeliver the fluid to the user when the infusion monitor unit 2850 iscoupled to the user. The delivery cannula 2854 is composed of ethylenetetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), polyetherblock amide, etc. and has a length of about 9 millimeters (mm). Thephysiological characteristic sensor 1300 is coupled to the housing 2852so as to be sandwiched between the first housing portion 2856 and thesecond housing portion 2858. Generally, a portion of the physiologicalcharacteristic sensor 1300 is sandwiched between the sealing members2862 to provide a fluid tight seal about the portion of thephysiological characteristic sensor 1300 contained within the housing2852.

The unit control module 2752 includes the circuit board 2760, the firstmodule 2762, the power source 2764, the communication component 2766 andthe second module 2714. In this example, the infusion monitor unit 2850determines the blood glucose level of the user at the infusion monitorunit 2850 via the unit control module 2752 and transmits this value tothe control module 422 of the fluid infusion device 400 via thecommunication component 2766 and the antenna 426, which may improveaccuracy of the blood glucose level value.

While the infusion set assembly 700 is described herein as usinginfusion monitor unit 708 to measure a blood glucose level of a user andto deliver a fluid to a user, it should be noted that the infusionmonitor unit 708 may be configured differently. For example, withreference to FIG. 141, an infusion monitor unit 2900 is shown. As theinfusion monitor unit 2900 includes the same or similar components asthe infusion set assembly 300 discussed with regard to FIGS. 11-26B, theinfusion monitor unit 2700 discussed with regard to FIGS. 130-133 andthe infusion monitor unit 2800 discussed with regard to FIGS. 136-139,the same reference numerals will be used to denote the same or similarcomponents.

With reference to FIG. 141, the infusion monitor unit 2900 is fluidlycoupled to a tube to define the fluid flow path for the fluid from thefluid reservoir 160 (FIG. 11) to the infusion monitor unit 2900. In thisexample, the infusion monitor unit 2900 includes the housing 2901, thecoupling member or adhesive patch 712, a delivery array 2902, a sensingarray 2904 and a unit control module 2903. The housing 2901 is composedof a polymeric material, and encloses the unit control module 2903. Thehousing 2901 may include one or more inlet ports for coupling to a tubeto supply the fluid to the infusion monitor unit 2900. The deliveryarray 2902 and the sensing array 2904 are each coupled to the housing2901. The delivery array 2902 is coupled to the housing 2901 to be influid communication with the fluid flow path to define the fluid flowpath from the fluid reservoir 160 (FIG. 11) to subdermal tissue of theuser. The sensing array 2904 is in communication with the unit controlmodule 2752 to provide signals from the sensing array 2904 to the unitcontrol module 2752. The adhesive patch 712 is affixes the infusionmonitor unit 2900 to an anatomy, such as the skin of the user. Theadhesive patch 712 is shown in FIGS. 141, 143 and 144 by generalreference for ease of illustration, but the adhesive patch 712 may havethe same thickness as that shown in FIG. 138. Thus, the infusion monitorunit 2900 includes the housing 2901 that is configured to be adhesivelycoupled to an anatomy of a user.

The delivery array 2902 comprises a plurality of microneedles 2906,which are shaded in the drawings for ease of reference. Each of theplurality of microneedles 2906 define a fluid flow path from the fluidreservoir 160 to the subdermal tissue of the user. The plurality ofmicroneedles 2906 is fluidly coupled to the tube to define the fluidflow path from the fluid reservoir 160 (FIG. 11) to the anatomy. Thetube may facilitate a fluidic connection between a connector, like theconnector 302, and the infusion monitor unit 2900, and the deliveryarray 2902 may extend from the housing 2901 and be inserted into ananatomy of a user to enable delivering the fluid, such as insulin, whilealso measuring a glucose level of the user. The connector is fluidlycoupled to the fluid reservoir 160 such that the fluid reservoir 160 ofthe fluid infusion device 400 is a fluid source, which is fluidlyconnected to the delivery array 2902.

The sensing array 2904 comprises a plurality of microneedles 2908, whichcooperate to define a glucose sensor that observes or measures a bloodglucose level of the user. Each microneedle 2908 is coupled to and incommunication with the unit control module 2903. In this example, thedelivery array 2902 is shown spaced apart from the sensing array 2904 bya distance D2900, however, the delivery array 2902 and the sensing array2904 may be arranged in various other configurations, if desired. Eachof the microneedles 2906, 2908 are about 500 micrometers (μm) to about2000 micrometers (μm) long. Each of the microneedles 2906 have anopening at the center to define the fluid flow path. The microneedles2908 are composed of a silicon, polymer or metal material. A platinum orgold layer is coated on the respective microneedle 2908 and the enzymeand other membranes (such as interference rejection membrane, enzyme,HSA, glucose limiting polymers) are added for measuring glucose. Inaddition, one or more of the microneedles 2908 may be designated as areference electrode and may be coated with silver or silver-chloride,while one or more of the microneedles 2908 may be designated as counterelectrodes where no chemistry coating is required. Thus, themicroneedles 2908 can cooperate to measure a blood glucose level of theuser.

For example, with reference to FIG. 142A-142D, top views of alternativeconfigurations of the delivery array 2902 and the sensing array 2904 areshown. In FIG. 142A, a delivery array 2902 a includes the microneedles2906 in a rectangular pattern next or directly adjacent to themicroneedles 2908 of a sensing array 2904 a. In FIG. 142B, a deliveryarray 2902 b includes the microneedles 2906 in a rectangular patternspaced a distance D2900 b apart from the microneedles 2908 of a sensingarray 2904 b. The distance D2900 b is different and less than thedistance D2900 (FIG. 141). In FIG. 142C, a delivery array 2902 cincludes a single one of the microneedles 2906 surrounded by themicroneedles 2908 of a sensing array 2904 c. In this example, thesensing array 2904 c includes four microneedles 2908 arranged in asquare pattern about the microneedle 2906. In FIG. 142C, the insertionforces are balanced due to the symmetric arrangement. In FIG. 142D, adelivery array 2902 d includes the microneedles 2906 surrounded by themicroneedles 2908 of a sensing array 2904 d. In this example, thesensing array 2904 d includes the microneedles 2908 arranged in acircular pattern about a cluster of three microneedles 2906.

As a further alternative configuration, with reference to FIG. 143, adelivery array 2902 e includes the microneedle 2908 from the sensingarray 2904. By positioning the microneedle 2908 in the delivery array2902 e, the microneedle 2908 may be used by the unit control module 2903to subtract out any insulin specific background noise present in thesensing array 2904. In this regard, some glucose sensors may besusceptible to insulin and the microneedle 2908 placed in proximity ofthe delivery array 2902 e acts as an insulin sensor that may be used toadjust the glucose reading value from the sensing array 2904. Anequation for determining the blood glucose reading value using thesensing array 2904 and the microneedle 2908 in the delivery array 2902 eis as follows:

Blood Glucose Level Value=(Msignal−scaling factor)*SAsignal  (1)

Wherein the Blood Glucose Level Value is the level of glucose measuredor observed by the unit control module 2903; the Msignal is the signalreading from the microneedle 2908 in the delivery array 2902 e; thescaling factor is a predetermined constant, linear, or non-linear input;and the SAsignal is the signal from the sensing array 2904.

As a further alternative configuration, with reference to FIG. 144, asensing array 2902 f includes an insulin sensor microneedle 2910. Bypositioning the insulin sensor microneedle 2910 in the sensing array2902 f, the insulin sensor microneedle 2910 may be used by the unitcontrol module 2903 to subtract out any insulin specific backgroundnoise present in the sensing array 2904 and to confirm that insulin isbeing delivered by the delivery array 2902. By including the insulinsensor microneedle 2910, the unit control module 2903 processes thesensor signals from the insulin sensor microneedle 2910 and determineswhether insulin is being delivered via the delivery array 2902. The unitcontrol module 2903 may also use the sensor signals from the insulinsensor microneedle 2910 to determine the blood glucose level value. Inthis regard, as discussed, the insulin sensor microneedle 2910 placed inthe sensing array 2902 f may be used to adjust the glucose reading valuefrom the sensing array 2904 f. An equation for determining the bloodglucose reading value using the sensing array 2904 f and the insulinsensor microneedle 2910 is as follows:

Blood Glucose Level Value=(IMsignal−ScalingFactor)*SAsignal  (2)

Wherein the Blood Glucose Level Value is the level of glucose measuredor observed by the unit control module 2903; the IMsignal is the signalreading from the insulin sensor microneedle 2910; ScalingFactor is apredetermined constant, linear, or non-linear input; and the SAsignal isthe signal from the sensing array 2904 f.

As a further alternative configuration, with reference to FIG. 145A, atop view of the delivery array 2902 and the sensing array 2904 areshown, and in FIG. 145B a side view is shown. In FIG. 145A, a deliveryarray 2902 g includes the microneedles 2906 spaced apart in a circularpattern surrounding the microneedles 2908 of a sensing array 2904 g. Inthis example, the microneedle 2906 labeled 1, may be used for apredetermined period of time to dispense the fluid, such as three days,and then the microneedle 2906 labeled 2 would be used for thepredetermined period of time to dispense the fluid, such as three days,before switching to the microneedle 2906 labeled 3. The microneedle 2906labeled 3 would be used for the predetermined period of time to dispensethe fluid, such as three days, before switching to the microneedle 2906labeled 4. This would minimize insulin tissue site loss. The switchingbetween the microneedles 2906 is controlled by the unit control module2903, which may actuate one or more microvalves, for example, to fluidlycouple the respective microneedle 2906 to the fluid source.

With reference back to FIG. 141, the unit control module 2903 includesthe circuit board 2760, the first module 2762, the power source 2764,the communication component 2766 and a second module 2914. In thisexample, the circuit board 2760 physically and electrically couples thesensing array 2904 to the first module 2962 and enables communicationbetween the first module 2762, the second module 2914, the power source2764 and the communication component 2766. The second module 2914 is incommunication with the power source 2764 and the first module 2762 viathe printed circuit board 2760. The second module 2914 includes at leastone processor and a computer readable storage device or media, which aremounted to the printed circuit board 2760. The processor can be anycustom made or commercially available processor, a central processingunit (CPU), an auxiliary processor among several processors associatedwith the second module 2914, a semiconductor based microprocessor (inthe form of a microchip or chip set), a macroprocessor, any combinationthereof, or generally any device for executing instructions. Thecomputer readable storage device or media may include volatile andnonvolatile storage in read-only memory (ROM), random-access memory(RAM), and keep-alive memory (KAM), for example. KAM is a persistent ornon-volatile memory that may be used to store various operatingvariables while the processor is powered down. The computer-readablestorage device or media may be implemented using any of a number ofknown memory devices such as PROMs (programmable read-only memory),EPROMs (electrically PROM), EEPROMs (electrically erasable PROM), flashmemory, or any other electrical, magnetic, and/or optical memory devicescapable of storing data, some of which represent executableinstructions, used by the second module 2914 in monitoring componentsassociated with the sensing array 2904.

The instructions may include one or more separate programs, each ofwhich comprises an ordered listing of executable instructions forimplementing logical functions. The instructions, when executed by theprocessor, receive and process input signals, perform logic,calculations, methods and/or algorithms for monitoring the components ofthe sensing array 2904, and generate signals to the first module 2762based on the logic, calculations, methods, and/or algorithms Althoughtwo modules 2762, 2914 are shown, embodiments of the infusion monitorunit 2900 can include any number of control modules that communicateover any suitable communication medium or a combination of communicationmediums and that cooperate to process signals received from the sensingarray 2904, perform logic, calculations, methods, and/or algorithms, andgenerate signals for transmission to a control module, such as thecontrol module 422, 822 of the respective fluid infusion device 400,800. In various embodiments, one or more instructions of the firstmodule 2762, when executed by the processor, receive and process signalsfrom the second module 2914 and transmit the signals from the secondmodule 2914 via the communication component 2766 to the antenna 426 ofthe fluid infusion device 400 to enable communication between theinfusion monitor unit 2900 and the fluid infusion device 400 (FIG. 11).In various embodiments, one or more instructions of the second module2914, when executed by the processor, receive and process signals fromthe sensing array 2904 to determine the blood glucose level of the user.Thus, in this example, the infusion monitor unit 2900 determines theblood glucose level of the user at the infusion monitor unit 2900 viathe unit control module 2903 and transmits this value to the controlmodule 422 of the fluid infusion device 400 via the communicationcomponent 2766 and the antenna 426, which may improve accuracy of theblood glucose level value.

While the infusion set assembly 700 is described herein as usinginfusion monitor unit 708 to measure a blood glucose level of a user andto deliver a fluid to a user, it should be noted that the infusionmonitor unit 708 may be configured differently. For example, withreference to FIG. 146, an infusion monitor unit 2950 is shown. As theinfusion monitor unit 2950 includes the same or similar components asthe infusion set assembly 300 discussed with regard to FIGS. 11-26B, thephysiological characteristic sensor 1300 discussed with regard to FIGS.53-55, the infusion monitor unit 2700 discussed with regard to FIGS.130-133, the infusion monitor unit 2800 discussed with regard to FIGS.136-139 and the infusion monitor unit 2900 discussed with regard toFIGS. 141-145B, the same reference numerals will be used to denote thesame or similar components.

With reference to FIG. 146, the infusion monitor unit 2900 is fluidlycoupled to a tube to define the fluid flow path for the fluid from thefluid reservoir 160 (FIG. 11) to the infusion monitor unit 2950. In thisexample, the infusion monitor unit 2950 includes a housing 2951, thecoupling member or adhesive patch 712, the delivery array 2902, thephysiological characteristic sensor 1300 and a unit control module 2953.The housing 2951 is composed of a polymeric material, and encloses theunit control module 2953. The housing 2951 may include one or more inletports for coupling to a tube to supply the fluid to the infusion monitorunit 2950. The delivery array 2902 and the physiological characteristicsensor 1300 are each coupled to the housing 2951. The delivery array2902 is coupled to the housing 2951 to be in fluid communication withthe fluid flow path to define the fluid flow path from the fluidreservoir 160 (FIG. 11) to subdermal tissue of the user. The deliveryarray 2902 is fluidly coupled to the tube to define the fluid flow pathfrom the fluid reservoir 160 (FIG. 11) to the anatomy. The tube mayfacilitate a fluidic connection between a connector, like the connector302, and the infusion monitor unit 2900, and delivery array 2902 mayextend from the housing 2802 and be inserted into an anatomy of a userto enable delivering the fluid, such as insulin. The connector isfluidly coupled to the fluid reservoir 160 such that the fluid reservoir160 of the fluid infusion device 400 is a fluid source, which is fluidlyconnected to the delivery array 2902.

The physiological characteristic sensor 1300 is in communication withthe unit control module 2953 to provide signals from the physiologicalcharacteristic sensor 1300 to the unit control module 2953. Thephysiological characteristic sensor 1300 is spaced apart from thedelivery array 2902 and is deployed in subcutaneous tissue associatedwith the user. The adhesive patch 712 is affixes the infusion monitorunit 2900 to an anatomy, such as the skin of the user. The adhesivepatch 712 is shown in FIG. 146 by general reference for ease ofillustration, but the adhesive patch 712 may have the same thickness asthat shown in FIG. 138. Thus, the infusion monitor unit 2950 includesthe housing 2951 that is configured to be adhesively coupled to ananatomy of a user.

As the unit control module 2953 is substantially the same as the unitcontrol module 2903, the unit control module 2953 will not be discussedin detail herein. Briefly, the unit control module 2953 includes thecircuit board 2760, the first module 2762, the power source 2764, thecommunication component 2766 and a second module 2954. The second module2954 includes at least one processor and a computer readable storagedevice or media, which are mounted to the printed circuit board 2760.The instructions associated with the second module 2954, when executedby the processor, receive and process input signals, perform logic,calculations, methods and/or algorithms for monitoring the components ofthe physiological characteristic sensor 1300, and generate signals tothe first module 2762 based on the logic, calculations, methods, and/oralgorithms. In various embodiments, one or more instructions of thefirst module 2762, when executed by the processor, receive and processsignals from the second module 2954 and transmit the signals from thesecond module 2954 via the communication component 2766 to an antenna ofa fluid infusion device, such as the antenna 426 of the fluid infusiondevice 400, 800, to enable communication between the infusion monitorunit 2900 and a fluid infusion device, such as the fluid infusion device400 (FIG. 11). In various embodiments, one or more instructions of thesecond module 2954, when executed by the processor, receive and processsignals from the physiological characteristic sensor 1300 to determinethe glucose level of the user. Thus, in this example, the infusionmonitor unit 2950 determines the glucose level of the user at theinfusion monitor unit 2950 via the unit control module 2953 andtransmits this value to a control module, such as the control module422, 822 of the respective fluid infusion device 400, 800 via thecommunication component 2766 and the antenna 426, which may improveaccuracy of the glucose level value.

While the infusion set assembly 700 is described herein as usinginfusion monitor unit 708 to measure a blood glucose level of a user andto deliver a fluid to a user, it should be noted that the infusionmonitor unit 708 may be configured differently. For example, withreference to FIG. 147, an infusion monitor unit 3000 is shown. As theinfusion monitor unit 3000 includes the same or similar components asthe infusion set assembly 300 discussed with regard to FIGS. 11-26B, theinfusion monitor unit 2700 discussed with regard to FIGS. 130-133, theinfusion monitor unit 2850 discussed with regard to FIG. 140, theinfusion monitor unit 2900 discussed with regard to FIGS. 141-145B andthe infusion monitor unit 2950 discussed with regard to FIG. 146, thesame reference numerals will be used to denote the same or similarcomponents.

With reference to FIG. 147, the infusion monitor unit 3000 is fluidlycoupled to a tube to define the fluid flow path for the fluid from thefluid reservoir 160 (FIG. 11) to the infusion monitor unit 3000. In thisexample, the infusion monitor unit 3000 includes a housing 3001, thecoupling member or adhesive patch 712, the sensing array 2904, thedelivery cannula 2854 and a unit control module 3003. The housing 3001is composed of a polymeric material, and encloses the unit controlmodule 3003. The housing 3001 may include one or more inlet ports forcoupling to a tube to supply the fluid to the infusion monitor unit3000. The sensing array 2904 and the delivery cannula 2854 are eachcoupled to the housing 3001. The delivery cannula 2854 is coupled to thehousing 3001 to be in fluid communication with the fluid flow path todefine the fluid flow path from the fluid reservoir 160 (FIG. 11) to thesubcutaneous tissue of the user. The sensing array 2904 is incommunication with the unit control module 3003 to provide signals fromthe sensing array 2904 to the unit control module 3003. The adhesivepatch 712 is affixes the infusion monitor unit 3000 to an anatomy, suchas the skin of the user. The adhesive patch 712 is shown in FIG. 147 bygeneral reference for ease of illustration, but the adhesive patch 712may have the same thickness as that shown in FIG. 138. Thus, theinfusion monitor unit 3000 includes the housing 3001 that is configuredto be adhesively coupled to an anatomy of a user.

As the unit control module 3003 is substantially the same as the unitcontrol module 2903, the unit control module 3003 will not be discussedin detail herein. Briefly, the unit control module 2953 includes thecircuit board 2760, the first module 2762, the power source 2764, thecommunication component 2766 and a second module 3006. The second module3006 includes at least one processor and a computer readable storagedevice or media, which are mounted to the printed circuit board 2760.The instructions associated with the second module 3006, when executedby the processor, receive and process input signals, perform logic,calculations, methods and/or algorithms for monitoring the components ofthe sensing array 2904, and generate signals to the first module 2762based on the logic, calculations, methods, and/or algorithms. In variousembodiments, one or more instructions of the first module 2762, whenexecuted by the processor, receive and process signals from the secondmodule 3006 and transmit the signals from the second module 3006 via thecommunication component 2766 to an antenna of a fluid infusion device,such as the antenna 426 of the fluid infusion device 400, 800 to enablecommunication between the infusion monitor unit 3000 and the fluidinfusion device 400 (FIG. 11), 800 (FIG. 39). In various embodiments,one or more instructions of the second module 3006, when executed by theprocessor, receive and process signals from the sensing array 2904 todetermine the blood glucose level of the user. Thus, in this example,the infusion monitor unit 3000 determines the blood glucose level of theuser at the infusion monitor unit 3000 via the unit control module 3003and transmits this value to a control module, such as the control module422, 822 of the respective fluid infusion device 400, 800 via thecommunication component 2766 and the antenna 426, which may improveaccuracy of the glucose level value.

While the infusion set assembly 700 is described herein as usinginfusion monitor unit 708 to measure a blood glucose level of a user andto deliver a fluid to a user, it should be noted that the infusionmonitor unit 708 may be configured differently. For example, withreference to FIGS. 148A and 148B, an infusion monitor unit 3050 isshown. As the infusion monitor unit 3050 includes the same or similarcomponents as the infusion set assembly 300 discussed with regard toFIGS. 11-26B, the physiological characteristic sensor 1300 discussedwith regard to FIGS. 53-55, the infusion monitor unit 2700 discussedwith regard to FIGS. 130-133, the infusion monitor unit 2800 discussedwith regard to FIGS. 136-139 and the infusion monitor unit 2900discussed with regard to FIGS. 141-145B, the same reference numeralswill be used to denote the same or similar components.

In FIG. 148A, a top view of the infusion monitor unit 3050 is shown, andin FIG. 148B a side view is shown. In FIG. 148A, the infusion monitorunit 3050 is fluidly coupled to a tube to define the fluid flow path forthe fluid from the fluid reservoir 160 (FIG. 11) to the infusion monitorunit 3050. In this example, the infusion monitor unit 3050 includes ahousing 3051, the coupling member or adhesive patch 712 (FIG. 148B), thedelivery array 2902, the physiological characteristic sensor 1300 andthe unit control module 2953. The housing 3051 is composed of apolymeric material, and encloses the unit control module 2953. Thehousing 3051 may include one or more inlet ports for coupling to a tubeto supply the fluid to the infusion monitor unit 3050. The deliveryarray 2902 and the physiological characteristic sensor 1300 are eachcoupled to the housing 3051. The delivery array 2902 is coupled to thehousing 3051 to be in fluid communication with the fluid flow path todefine the fluid flow path from the fluid reservoir 160 (FIG. 11) tosubdermal tissue of the user. The microneedles 2906 are spaced apartabout the physiological characteristic sensor 1300. The physiologicalcharacteristic sensor 1300 is in communication with the unit controlmodule 2953 to provide signals from the physiological characteristicsensor 1300 to the unit control module 2953. The physiologicalcharacteristic sensor 1300 is spaced apart from the delivery array 2902and is deployed in subcutaneous tissue associated with the user. Theadhesive patch 712 is affixes the infusion monitor unit 2900 to ananatomy, such as the skin of the user. The adhesive patch 712 is shownin FIG. 148B by general reference for ease of illustration, but theadhesive patch 712 may have the same thickness as that shown in FIG.138. The infusion monitor unit 3050 includes the housing 3051 that isconfigured to be adhesively coupled to an anatomy of a user. Thus, inthis example, the infusion monitor unit 3050 determines the bloodglucose level of the user at the infusion monitor unit 3050 via the unitcontrol module 3053 and transmits this value to a control module, suchas the control module 422, 822 of the respective fluid infusion device400, 800 via the communication component 2766 and the antenna 426, whichmay improve accuracy of the glucose level value.

While the infusion set assembly 700 is described herein as usinginfusion monitor unit 708 to measure a blood glucose level of a user andto deliver a fluid to a user, it should be noted that the infusionmonitor unit 708 may be configured differently. For example, withreference to FIG. 149, an infusion monitor unit 3100 is shown. As theinfusion monitor unit 3100 includes the same or similar components asthe infusion set assembly 300 discussed with regard to FIGS. 11-26B, thephysiological characteristic sensor 1300 discussed with regard to FIGS.53-55, the infusion monitor unit 2700 discussed with regard to FIGS.130-133, the infusion monitor unit 2800 discussed with regard to FIGS.136-139 and the infusion monitor unit 2900 discussed with regard toFIGS. 141-145B, the same reference numerals will be used to denote thesame or similar components.

With reference to FIG. 149, the infusion monitor unit 3100 is fluidlycoupled to a tube to define the fluid flow path for the fluid from thefluid reservoir 160 (FIG. 11) to the infusion monitor unit 3100. In thisexample, the infusion monitor unit 3100 includes the housing 2951, thecoupling member or adhesive patch 712, the delivery array 2902, thephysiological characteristic sensor 1300, an insulin sensor 3102 and aunit control module 3103. The insulin sensor 3102 is coupled to thephysiological characteristic sensor 1300, and observes an amount ofinsulin. The insulin sensor 3102 is in communication with the unitcontrol module 3103. The sensor signals from the insulin sensor 3102 maybe used by the unit control module 3103 to determine whether thedelivery array 2902 is dispensing the fluid and to correct a value ofthe blood glucose level observed by the physiological characteristicsensor 1300. The delivery array 2902 and the physiologicalcharacteristic sensor 1300 are each coupled to the housing 2951. Thedelivery array 2902 is coupled to the housing 2951 to be in fluidcommunication with the fluid flow path to define the fluid flow pathfrom the fluid reservoir 160 (FIG. 11) to subdermal tissue of the user.The physiological characteristic sensor 1300 is in communication withthe unit control module 3103 to provide signals from the physiologicalcharacteristic sensor 1300 to the unit control module 3103. Thephysiological characteristic sensor 1300 is spaced apart from thedelivery array 2902 and is deployed in subcutaneous tissue associatedwith the user. The adhesive patch 712 is affixes the infusion monitorunit 3100 to an anatomy, such as the skin of the user. The adhesivepatch 712 is shown in FIG. 147 by general reference for ease ofillustration, but the adhesive patch 712 may have the same thickness asthat shown in FIG. 138. Thus, the infusion monitor unit 3100 includesthe housing 2951 that is configured to be adhesively coupled to ananatomy of a user.

As the unit control module 3103 is substantially the same as the unitcontrol module 2903, the unit control module 3103 will not be discussedin detail herein. Briefly, the unit control module 3103 includes thecircuit board 2760, the first module 2762, the power source 2764, thecommunication component 2766 and a second module 3104. The second module3104 includes at least one processor and a computer readable storagedevice or media, which are mounted to the printed circuit board 2760.The instructions associated with the second module 3104, when executedby the processor, receive and process input signals, perform logic,calculations, methods and/or algorithms for monitoring the components ofthe physiological characteristic sensor 1300 and the insulin sensor3102, and generate signals to the first module 2762 based on the logic,calculations, methods, and/or algorithms. In various embodiments, one ormore instructions of the first module 2762, when executed by theprocessor, receive and process signals from the second module 2964 andtransmit the signals from the second module 2964 via the communicationcomponent 2766 to an antenna of a fluid infusion device, such as theantenna 426 of the fluid infusion device 400, 800 to enablecommunication between the infusion monitor unit 3100 and the fluidinfusion device 400 (FIG. 11), 800 (FIG. 39). In various embodiments,one or more instructions of the second module 3104, when executed by theprocessor, receive and process signals from the physiologicalcharacteristic sensor 1300 and the insulin sensor 3102 to determine theglucose level of the user. In some examples, the unit control module3103 processes the sensor signals from the insulin sensor 3102 anddetermines whether insulin is being delivered via the delivery array2902. The unit control module 3103 may also use the sensor signals fromthe insulin sensor 3102 to determine the blood glucose level value usingequation (2) discussed above. In this regard, as discussed, since someglucose sensors may be susceptible to insulin (meaning, their sensorsignal artificially increases in the presence of insulin), the insulinsensor 3102 is used to adjust the glucose reading value from thephysiological characteristic sensor 1300. Thus, in this example, theinfusion monitor unit 3100 determines the blood glucose level of theuser at the infusion monitor unit 3100 via the unit control module 3103and transmits this value to a control module, such as the control module422, 822 of the respective fluid infusion device 400, 800 via thecommunication component 2766 and the antenna 426, which may improveaccuracy of the blood glucose level value.

While the infusion set assembly 700 is described herein as usinginfusion monitor unit 708 to measure a blood glucose level of a user andto deliver a fluid to a user, it should be noted that the infusionmonitor unit 708 may be configured differently. For example, withreference to FIG. 150, an infusion monitor unit 3150 is shown. As theinfusion monitor unit 3150 includes the same or similar components asthe infusion set assembly 300 discussed with regard to FIGS. 11-26B, thephysiological characteristic sensor 1300 discussed with regard to FIGS.53-55, the infusion monitor unit 2700 discussed with regard to FIGS.130-133, the infusion monitor unit 2800 discussed with regard to FIGS.136-139 and the infusion monitor unit discussed with regard to FIG. 140,the same reference numerals will be used to denote the same or similarcomponents.

With reference to FIG. 150, the infusion monitor unit 3150 is fluidlycoupled to a tube to define the fluid flow path for the fluid from thefluid reservoir 160 (FIG. 11) to the infusion monitor unit 3150. In thisexample, the infusion monitor unit 3150 includes a housing 3152, thedelivery cannula 2854, a glucose sensor 3154 and a unit control module3156. The housing 3152 is composed of a polymeric material, and enclosesthe unit control module 3156. The housing 3152 may include one or moreinlet ports for coupling to a tube to supply the fluid to the infusionmonitor unit 3150. An adhesive patch, not shown, may be used to affixthe infusion monitor unit 3150 to an anatomy, such as the skin of theuser. In some examples, the adhesive patch may be composed of abreathable material and an adhesive layer. The breathable material layeris composed of a cloth or bandage-like material that is composed of, forexample, nonwoven polyurethane. The adhesive layer of the adhesive patchcan be composed of a hydrogel based, silicone-based, or acrylic-basedadhesive. The adhesive patch is affixed to the infusion monitor unit3150 via a double sided pressure sensitive adhesive. Thus, the infusionmonitor unit 3150 includes the housing 3152 that is configured to beadhesively coupled to an anatomy of a user.

In this example, with reference to FIG. 151, the glucose sensor 3154 isshown in greater detail. The glucose sensor 3154 includes two electrodepairs 3158 a-3158 b; 3160 a-3160 b; however, the glucose sensor 3154 mayinclude any number of electrode pairs. The electrode pairs 3158 a-3158b; 3160 a-3160 b include a positively charged electrode 3158 a, 3160 aand a negatively charged electrode 3158 b, 3160 b. In this example, theglucose sensor 3154 uses iontophoresis to detect a blood glucose level.The amount of current passed between the electrode pairs 3158 a-3158 b;3160 a-3160 b may be minimized to reduce tissue heating. The two sets ofelectrode pairs 3158 a-3158 b; 3160 a-3160 b enable redundant sensing.This enables the unit control module 3156 to average the signals fromboth electrode pairs 3158 a-3158 b; 3160 a-3160 b. Alternatively, theunit control module 3156 may collect the signal from both electrodepairs 3158 a-3158 b; 3160 a-3160 b and only use the signal from theelectrode 3158 a-3158 b; 3160 a-3160 b that is believed to be moreaccurate at a given point in time. As a further alternative, the unitcontrol module 3156 may alternate back-and-forth between which electrodepair 3158 a-3158 b; 3160 a-3160 b is turn-on to minimize local tissueheating.

As the unit control module 3156 is substantially the same as the unitcontrol module 2903, the unit control module 3156 will not be discussedin detail herein. Briefly, the unit control module 3156 includes thecircuit board 2760, the first module 2762, the power source 2764, thecommunication component 2766 and a second module 3162. The second module3162 includes at least one processor and a computer readable storagedevice or media, which are mounted to the printed circuit board 2760.The instructions associated with the second module 3162, when executedby the processor, receive and process input signals, perform logic,calculations, methods and/or algorithms for monitoring the components ofthe glucose sensor 3154 and supplying power to the components of theglucose sensor 3154, and generate signals to the first module 2762 basedon the logic, calculations, methods, and/or algorithms. In variousembodiments, one or more instructions of the first module 2762, whenexecuted by the processor, receive and process signals from the secondmodule 3162 and transmit the signals from the second module 3162 via thecommunication component 2766 to an antenna of a fluid infusion device,such as the antenna 426 of the fluid infusion device 400, 800 to enablecommunication between the infusion monitor unit 3150 and the fluidinfusion device 400 (FIG. 11), 800 (FIG. 39). In various embodiments,one or more instructions of the second module 3162, when executed by theprocessor, receive and process signals from the glucose sensor 3154 todetermine the blood glucose level of the user. Thus, in this example,the infusion monitor unit 3150 determines the blood glucose level of theuser at the infusion monitor unit 3150 via the unit control module 3156and transmits this value to a control module, such as the control module422, 822 of the respective fluid infusion device 400, 800 via thecommunication component 2766 and the antenna 426, which may improveaccuracy of the glucose level value.

While the infusion set assembly 700 is described herein as usinginfusion monitor unit 708 to measure a blood glucose level of a user andto deliver a fluid to a user, it should be noted that the infusionmonitor unit 708 may be configured differently. For example, withreference to FIG. 152, an infusion monitor unit 3200 is shown. As theinfusion monitor unit 3200 includes the same or similar components asthe infusion set assembly 300 discussed with regard to FIGS. 11-26B, thephysiological characteristic sensor 1300 discussed with regard to FIGS.53-55, the infusion monitor unit 2700 discussed with regard to FIGS.130-133, the infusion monitor unit 2800 discussed with regard to FIGS.136-139 and the infusion monitor unit discussed with regard to FIG. 140,the same reference numerals will be used to denote the same or similarcomponents.

With reference to FIG. 152, the infusion monitor unit 3200 is fluidlycoupled to a tube to define the fluid flow path for the fluid from thefluid reservoir 160 (FIG. 11) to the infusion monitor unit 3200. Fluidmay be dispensed from the infusion monitor unit 3200 via the glucosesensor 3204. In some examples, the glucose sensor 3204 is fluidlycoupled to the tube to define the fluid flow path from the fluidreservoir 160 (FIG. 11) to the anatomy. The tube may facilitate afluidic connection between a connector, like the connector 302, and theinfusion monitor unit 3200, and glucose sensor 3204 may extend from thehousing 3202 and be inserted into an anatomy of a user to enabledelivering the fluid, such as insulin, while also measuring a glucoselevel of the user. The connector is fluidly coupled to the fluidreservoir 160 such that the fluid reservoir 160 of the fluid infusiondevice 400 is a fluid source, which is fluidly connected to the infusionmonitor unit 3200. Alternatively, the infusion monitor unit 3200 mayinclude the delivery array 2902 to dispense the fluid.

In this example, the infusion monitor unit 3200 includes a housing 3202,a glucose sensor 3204 and a unit control module 3206. The housing 3202is composed of a polymeric material, and encloses the unit controlmodule 3206. The housing 3202 may include one or more inlet ports forcoupling to a tube to supply the fluid to the infusion monitor unit3200. An adhesive patch, not shown, may be used to affix the infusionmonitor unit 3200 to an anatomy, such as the skin of the user. In someexamples, the adhesive patch may be composed of a breathable materialand an adhesive layer. The breathable material layer is composed of acloth or bandage-like material that is composed of, for example,nonwoven polyurethane. The adhesive layer of the adhesive patch can becomposed of a hydrogel based, silicone-based, or acrylic-based adhesive.The adhesive patch is affixed to the infusion monitor unit 3200 via adouble sided pressure sensitive adhesive. Thus, the infusion monitorunit 3200 includes the housing 3202 that is configured to be adhesivelycoupled to an anatomy of a user.

In this example, the glucose sensor 3204 includes two glucose sensorassemblies 3204 a, 3204 b. The glucose sensor assembly 3204 a includesthe working electrode 1310, the counter electrode 1308 and the referenceelectrode 1306. The glucose sensor assembly 3204 b includes a workingelectrode 1310 b, a counter electrode 1308 b and a reference electrode1306 b. The working electrode 1310 b is devoid of the glucose oxidaseenzyme, and thus, the glucose sensor assembly 3204 b observes ormeasures interferences in the glucose sensor assembly 3204 ameasurement.

As the unit control module 3206 is substantially the same as the unitcontrol module 2903, the unit control module 3206 will not be discussedin detail herein. Briefly, the unit control module 3156 includes thecircuit board 2760, the first module 2762, the power source 2764, thecommunication component 2766 and a second module 3208. The second module3208 includes at least one processor and a computer readable storagedevice or media, which are mounted to the printed circuit board 2760.The instructions associated with the second module 3208, when executedby the processor, receive and process input signals, perform logic,calculations, methods and/or algorithms for monitoring the components ofthe glucose sensor 3204 and supplying power to the components of theglucose sensor 3204, and generate signals to the first module 2762 basedon the logic, calculations, methods, and/or algorithms. In variousembodiments, one or more instructions of the first module 2762, whenexecuted by the processor, receive and process signals from the secondmodule 3208 and transmit the signals from the second module 3208 via thecommunication component 2766 to an antenna of a fluid infusion device,such as the antenna 426 of the fluid infusion device 400, 800 to enablecommunication between the infusion monitor unit 3200 and the fluidinfusion device 400 (FIG. 11), 800 (FIG. 39). In various embodiments,one or more instructions of the second module 3162, when executed by theprocessor, receive and process signals from the glucose sensor 3204 todetermine the blood glucose level of the user based on the followingequation:

Blood Glucose Level Value=Signal1−ScalingFactor*Signal2  (3)

Wherein the Blood Glucose Level Value is the level of glucose measuredor observed by the second module 3208; the Signal1 is the signal readingfrom the glucose sensor assembly 3204 a; the ScalingFactor is apredetermined constant, linear, or non-linear input; and the Signal2 isthe signal from the glucose sensor assembly 3204 b. Thus, in thisexample, the infusion monitor unit 3200 determines the blood glucoselevel of the user at the infusion monitor unit 3200 via the unit controlmodule 3156 and transmits this value to a control module, such as thecontrol module 422, 822 of the respective fluid infusion device 400, 800via the communication component 2766 and the antenna 426, which mayimprove accuracy of the glucose level value.

In addition, it should be noted that any of the physiologicalcharacteristic sensors 716, 1000, 1300, 2200, 2250, 2300, 2704, 2806,3152, 3204 described herein can include a filter, electrochemicalconversion and interference rejection membrane, if desired.

While at least one exemplary embodiment has been presented in theforegoing detailed description, it should be appreciated that a vastnumber of variations exist. It should also be appreciated that theexemplary embodiment or embodiments described herein are not intended tolimit the scope, applicability, or configuration of the claimed subjectmatter in any way. Rather, the foregoing detailed description willprovide those skilled in the art with a convenient road map forimplementing the described embodiment or embodiments. It should beunderstood that various changes can be made in the function andarrangement of elements without departing from the scope defined by theclaims, which includes known equivalents and foreseeable equivalents atthe time of filing this patent application.

It should be understood that various aspects disclosed herein may becombined in different combinations than the combinations specificallypresented in the description and accompanying drawings. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques). In addition, while certain aspects of this disclosure aredescribed as being performed by a single module or unit for purposes ofclarity, it should be understood that the techniques of this disclosuremay be performed by a combination of units or modules associated with,for example, a medical device.

In one or more examples, the described techniques may be implemented inhardware, software, firmware, or any combination thereof. If implementedin software, the functions may be stored as one or more instructions orcode on a computer-readable medium and executed by a hardware-basedprocessing unit. Computer-readable media may include non-transitorycomputer-readable media, which corresponds to a tangible medium such asdata storage media (e.g., RAM, ROM, EEPROM, flash memory, or any othermedium that can be used to store desired program code in the form ofinstructions or data structures and that can be accessed by a computer).

Instructions may be executed by one or more processors, such as one ormore digital signal processors (DSPs), general purpose microprocessors,application specific integrated circuits (ASICs), field programmablelogic arrays (FPGAs), or other equivalent integrated or discrete logiccircuitry. Accordingly, the term “processor” as used herein may refer toany of the foregoing structure or any other physical structure suitablefor implementation of the described techniques. Also, the techniquescould be fully implemented in one or more circuits or logic elements.

What is claimed is:
 1. A wearable fluid infusion device devoid of a userinterface, the wearable fluid infusion device comprising: a housingconfigured to accommodate a removable fluid reservoir, the housinghaving a largest dimension and a smallest dimension; a drive systemconfigured to be serially coupled to the removable fluid reservoir suchthat a combined dimension of the drive system and the removable fluidreservoir is less than or equal to the largest dimension; a planarbattery configured to supply power to the drive system, the planarbattery having a plurality of faces comprising one or more faces havinga largest area, and the planar battery being situated such that the oneor more faces are parallel to the largest dimension and the smallestdimension; and a means for coupling the housing with an adhesive plateconfigured to couple the wearable fluid infusion device to a user. 2.The wearable fluid infusion device of claim 1, wherein the housing isconfigured to accommodate the removable fluid reservoir via an openingin the housing, and wherein the opening is configured to couple with aninfusion set connector.
 3. The wearable fluid infusion device of claim1, further comprising a charging coil configured to supply power to theplanar battery.
 4. The wearable fluid infusion device of claim 3,wherein a wireless charging mat is configured to transfer power to thecharging coil via induction.
 5. The wearable fluid infusion device ofclaim 3, wherein a charging dongle is configured to transfer power tothe charging coil via induction.
 6. The wearable fluid infusion deviceof claim 5, wherein the charging dongle is configured to magneticallyattach to the wearable fluid infusion device when transferring power tothe charging coil.
 7. The wearable fluid infusion device of claim 1,wherein the adhesive plate is configured to magnetically couple with thehousing.
 8. The wearable fluid infusion device of claim 1, wherein theadhesive plate is configured to couple with the housing based on acoupling slot and a rail configured to fit within the coupling slot. 9.The wearable fluid infusion device of claim 1, wherein the adhesiveplate is composed of a rigid polymeric material.
 10. The wearable fluidinfusion device of claim 1, wherein the adhesive plate is composed of aflexible polymeric material.
 11. A wearable fluid infusion device devoidof a user interface, the wearable fluid infusion device comprising: ahousing configured to accommodate a removable fluid reservoir via afirst opening in the housing and to accommodate a disposable battery viaa second opening in the housing; a drive system configured to dispensefluid the removable fluid reservoir; and means for coupling the housingwith an adhesive plate configured to couple the wearable fluid infusiondevice to a user.
 12. The wearable fluid infusion device of claim 11,wherein the first opening is configured to couple with an infusion setconnector.
 13. The wearable fluid infusion device of claim 11, whereinthe second opening is configured to couple with a battery cap.
 14. Thewearable fluid infusion device of claim 11, wherein the housing has aplurality of faces comprising one or more faces having a smallest area,and wherein the first opening and the second opening are located on oneof the one or more faces.
 15. The wearable fluid infusion device ofclaim 11, wherein the adhesive plate is configured to magneticallycouple with the housing.
 16. The wearable fluid infusion device of claim11, wherein the adhesive plate is configured to couple with the housingbased on a coupling slot and a rail configured to fit within thecoupling slot.
 17. The wearable fluid infusion device of claim 11,wherein the adhesive plate is configured to couple with the housingbased on mechanical fasteners.
 18. The wearable fluid infusion device ofclaim 11, wherein the adhesive plate comprises a sleeve configured toretain the wearable fluid infusion device within the sleeve viafriction.
 19. The wearable fluid infusion device of claim 11, whereinthe adhesive plate is composed of a rigid polymeric material.
 20. Thewearable fluid infusion device of claim 11, wherein the adhesive plateis composed of a flexible polymeric material.